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Development of living guidelines

For cochlear implantation in adults

Background

Developing a consistent approach to optimising care for adults experiencing hearing loss who may not receive adequate benefit from hearing aids are essential to overcoming the burden affecting 1 in 5 adults globally1.

In many countries, adults do not have their hearing assessed as part of regular health check-ups.

Of those who receive hearing checks and are diagnosed with severe, profound, or moderate sloping to profound Sensorineural Hearing Loss (SNHL), few are referred to an appropriately qualified hearing specialist to examine whether an implantable hearing device is indicated as the most beneficial treatment option.3

There is currently no global guidance or set of guidelines that are applicable for Adult Cochlear Implantation (CI).

Click here to download a copy of the guidelines for public consultation

The standard of care for adults with hearing loss should include treatments that best improve the individual’s quality of life through optimising hearing function, social participation and engagement. For adults with severe to profound or moderate sloping to profound sensorineural hearing loss, standard of care should include accurate identification, diagnosis and timely referral to an appropriate specialist centre for assessment and counselling. When indicated as a treatment option, the patient should be advised by an appropriate healthcare professional about access to cochlear implantation and aftercare.

Clinical guidelines are integral to ensuring that healthcare decisions are based on the best available evidence. In 2021, an international group of cochlear implant users and experts in the fields of otology, audiology and hearing science were brought together to form a Task Force in partnership with the Cochlear Implant International Community of Action (CIICA). The Cochlear Implant Task Force (CI Task Force) was established to develop living practice guidelines and guidance that can be adapted and adopted in country, in order to optimise the care for adults indicated for cochlear implants.

The Living Guidelines development process requires public consultation and feedback on the recommendations and good practice statements. The current document has been prepared for public consultation covering a period from International Cochlear Implant Day, 25th February 2023 until the 31st May 2023. The Task Force warmly welcomes feedback from all members of the global healthcare community.

To have your say, visit the MAGICapp link HERE for the full guidelines, recommendations, and technical report. You can submit your comments using the feedback tab located under each recommendation in MAGICapp OR by downloading and using the submission template and emailing it to guidelines@htanalysts.com.au. Please note you need to sign into MAGICapp to leave a comment and these comments will be public. If using the submission template, the feedback, identifiable information will only be visible to the administrator and remain anonymous. All feedback will be considered by the Task Force, to support their evaluation of the recommendations and good practice statements included in the guidelines.

Click to hear from Task Force Co-Chair Professor Angel Ramos- Macias as he presents a high level overview of the guidelines and their significance.

Click to hear from Task Force member Professor Bamini Gopinath as she explains the methodology and background to the process.

Click to hear from Task Force member and cochlear implant user Peter Wolnizer as he explains his role and the importance of the patient voice in the process.

Click to hear Meredith Holcomb Au.D. Co-Chair of the Living Guidelines Task Force explain the rationale behind the Living Guidelines.

Living Guidelines patient flow chart

Click the button below to download Living Guidelines Patient Flow Chart.

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methodology and guidelines

Click here to access a short learning module that walks through the methodology and guidelines in a simple format.

Learning module

Living Guidelines linked from MAGICapp

Magicapp

HEARING LOSS SCREENING AND ASSESSMENT

According to the WHO, a person is considered to have hearing loss if they are not able to hear as well as someone with normal hearing, meaning they have a hearing threshold of 20 dBHL or better in both ears [7]. To standardise the way in which the severity of hearing loss is reported, WHO has adopted a grading system based on audiometric measurements (see section 2.1 Table 1). The Living Guidelines will also adopt this same grading system.

Hearing loss can range from mild to complete or total hearing loss and can affect one or both ears. Common causes include congenital hearing loss, chronic middle ear infections, noise-induced hearing loss, age-related hearing loss and ototoxic drugs that damage the inner ear.

The impact of hearing loss and delayed intervention can be substantial and far-reaching. Even a minor reduction in hearing sensitivity, as defined by the WHO in the International Classification of Functioning, Disability and Health (ICF), can be considered a potentially disabling condition [7]. The degree of disability experienced by a person with hearing loss depends not only on their hearing impairment but also on the physical, social and attitudinal environment in which they live and their access to quality healthcare services. 

If a person with hearing loss does not receive proper care, they are likely to face greater limitations in their daily functioning and higher levels of disability, leading to social isolation, loneliness, frustration and a loss of independence [7]. Hearing loss has also been linked to decreased quality of life, cognitive decline and depression [10][12] and there is a growing body of evidence suggesting an association between hearing loss in older adults and neurocognitive disorders, such as dementia [11]. Additionally, hearing loss can also have an impact on the individuals close to them, such as family and friends [142]. 

Despite being the most common sensory deficit among older adults, hearing loss is often under-recognised and poorly managed [9]. This costs the global economy USD $980 billion annually. In a study conducted in the United States, only 34% of primary care physicians were documented to routinely screen their older patients for hearing function [143] and in a Danish study, just 7% of general practitioners were reported to enquire about hearing function in older patients [144]. In addition, adults wait for nearly 9 years before seeking help for their hearing loss [133].

Early identification is the first step in addressing hearing loss. Primary healthcare practitioners play a crucial role in detecting hearing loss in adults. As the first point of contact for many patients, they are in a unique position to identify hearing loss early on and make a referral for a full audiological assessment by a hearing healthcare specialist. 

RECOMMENDATION 1/2

RESEARCH QUESTION
PROSPERO

Question 1 – Who should hearing loss screening be offered to?

Question 2 – What screening tools (questionnaires or assessments) should be used by primary healthcare professionals to screen for hearing loss?

  • What is the intra-rater reliability of each screening tool?
  • What is the diagnostic accuracy of each screening tool?

Hearing loss screening should be offered to adults from the age of 50 years (unless concerns about hearing loss are expressed before this age) using the single question:

“Do you feel you have hearing loss?”

If a person answers “yes”, the next steps should be informed as per the hearing loss referral recommendations of these Living Guidelines. 

Hearing loss screening should be administered at the frequency of 1–3 years [7][22][26].

GOOD PRACTICE STATEMENTS

  • Hearing loss screening can be administered by any primary healthcare practitioner including General Practitioners.
  • Before screening for hearing loss, primary healthcare practitioners should explain the purpose of screening and common symptoms and signs of hearing loss. These include [111]: 
    • Having trouble hearing over the phone.
    • Finding it hard to follow conversations when two or more people are talking.
    • Needing to ask people to regularly repeat what they are saying.
    • Needing to turn up the television volume so loud that others complain.
    • Having trouble hearing because of background noise.
    • Thinking that others seem to mumble.
    • Finding different speakers difficult to hear, such as children and softly spoken persons.

If a person is unable to answer the single question with “yes” or “no’’, primary healthcare practitioners should clarify and further explain these signs and symptoms to the individual being screened. 

  • Before screening for hearing loss, primary healthcare practitioners should explain the importance of hearing health and early hearing loss interventions including the avoided risk of cognitive impairment and dementia [110].
  • If a person is considered at a higher risk for hearing loss, hearing loss screening should be administered before the age of 50 years and/or more frequently [7][22][26]. Such risk factors include: 
    • cardiovascular disease,
    • diabetes,
    • ototoxicity,
    • kidney dysfunction,
    • noise exposure,
    • tinnitus, and
    • significant family history.
  • If a person, their family and/or friends have expressed concern(s) about an individual’s hearing loss before the age of 50 years, hearing loss screening should be administered. Such concerns may include [111]: 
    • Having trouble hearing over the phone.
    • Finding it hard to follow conversations when two or more people are talking.
    • Needing to ask people to regularly repeat what they are saying.
    • Needing to turn up the television volume so loud that others complain.
    • Having trouble hearing because of background noise.
    • Thinking that others seem to mumble.
    • Struggling when women and children speak.
  • In addition to the single question hearing loss screener, and if resources allow, primary healthcare practitioners may also administer or recommend other validated hearing loss screening tools including mobile technologies designed to detect hearing loss

 [50][51][56][62][68][72][73][74][76][77][78][79][80][88][89][91][92][94][95][109].

EVIDENCE TO DECISION

BENEFITS AND HARMS
Substantial net benefits of the recommended alternative
Overall, the benefits of referral for a full hearing assessment far outweigh any potential harms. The balance between benefits, harms and burdens is uncertain due to a low certainty of evidence.

The benefits of early detection and intervention far outweigh any potential harm. The potential harms such as the overuse of resources or excessive referrals to hearing health care specialists must be considered.
The effects of untreated hearing loss can result in social isolation, frustration, loss of independence, depression decreased quality of life, and even cognitive decline and dementia.

VALUES AND PREFERENCES
No substantial variability expected
It is not expected that people will decline hearing loss screening using the single question, “Do you feel you have hearing loss?” or that primary health care practitioners will not use this screening tool.

RESOURCES AND OTHER CONSIDERATIONS
Important issues, or potential issues not investigated
Administering hearing loss screening using the single question, ‘Do you feel you have hearing loss?” is not expected to disproportionately use or misuse resources in primary healthcare settings. However, a formal health economic analysis was not conducted as part of this review.

RATIONALE

Despite hearing loss being the most common sensory deficit in older persons, it is often under-recognised and poorly managed [9]. Primary health care practitioners must screen for hearing loss to support early intervention and refer patients toward the appropriate care pathway to optimise their audiological health and promote healthy ageing. 

Sixty-four citations corresponding to 64 cross-sectional (cohort type diagnostic accuracy) studies were identified in the literature search (please see the Technical Report for an overview of these citations). Across the studies, there were over 30 screening tools (questionnaires or assessments) investigated. 

Following a review of existing guidelines and consultation with the CI Task Force revealed that a single question should be used to screen for hearing loss. Other tools identified via the literature search were either too resource intensive or unable to be performed by all primary health care professionals globally. The WHO hearing guidelines also endorse the use of a single yes/no question for hearing loss screening [22].

Three included studies, Strawbridge 2017 [23], Deepthi 2012 [24], and Everett 2020 [25] used a version of the question “Do you feel you have hearing loss?” as the screening tool. Based on these studies and international guidelines, it is recommended that hearing loss screening should be implemented starting at age 50 and repeated once every 1-3 years [7][22][26].

For more detailed information on the development of this recommendation, please see the Technical Report.

HEARING HEALTHCARE SPECIALIST REFERRAL

Primary healthcare practitioners play a crucial role in detecting hearing loss in adults, especially general practitioners who are often the first point of contact for many patients. With the opportunity to detect hearing loss early, practitioners can refer patients to the appropriate hearing health care specialists to address their hearing concerns [145]. A population-based consumer survey in the United States found that people with hearing loss are five times more likely to seek a hearing solution if their general practitioner gives a positive recommendation for hearing healthcare [133]. As such, primary health care practitioners can play an instrumental role in guiding patients to make appropriate and timely choices for addressing their hearing loss.

RECOMMENDATION 3

RESEARCH QUESTION

Question 3 – Once adults with any level of hearing loss are identified, who and when should they be referred to for hearing healthcare evaluation/management?

Consensus recommendation

For an adult who presents for the first time with any level of hearing loss, or in whom hearing difficulties are suspected, the primary healthcare professional should:

  • arrange a referral to a hearing healthcare specialist for a full audiological assessment, and
  • check for impacting factors such as impacted wax and acute infections (e.g. otitis externa, otitis media and otitis media with effusion), and
  • if sudden or rapid onset hearing loss is suspected or hearing loss is not explained by acute external or middle ear causes, additional immediate referral to an ENT specialist or an emergency department is warranted.

GOOD PRACTICE STATEMENT

  • If an adult is diagnosed with impacted wax or acute infections, please follow your local guidelines for the management of these.
  • If a full audiological assessment is required, refer to an audiologist if available in your country (or equivalent) and/or to an ENT specialist.

EVIDENCE TO DECISION

BENEFITS AND HARMS

Substantial net benefits of the recommended alternative
The balance between benefits, harms and burdens is uncertain due to a lack of evidence identified. The potential harms include the misuse of resources or over-referral to hearing healthcare specialists. However, it is not anticipated that a referral for a full audiological assessment will cause any harm to the individual, compared to not being referred. The impacts of hearing loss and delayed intervention are far-reaching, including decreased functional ability and a loss of ability to communicate with others. Hearing loss can lead to social isolation, loneliness, frustration and a loss of independence and is strongly associated with decreased quality of life, cognitive decline, depression and dementia [10][12][11]. Overall, the benefits thus outweigh the harms.

VALUES AND PREFERENCES

No substantial variability expected
There is no reason to suspect that adults with any level of hearing loss would not accept a referral for a full audiological assessment. Some adults may choose not to have a full audiological assessment because of the potential financial burden, personal preferences and/or access issues.

RESOURCES AND OTHER CONSIDERATIONS

Important issues, or potential issues not investigated
For the primary healthcare practitioner to exclude certain conditions and refer an adult for a full audiological examination is not expected to disproportionately use or misuse resources in primary healthcare settings. However, a formal health economic analysis was not conducted as a part of this review.
It is acknowledged that some countries may not have audiologist assessments or ENT specialist assessments reimbursed and some patients may incur out-of-pocket costs if referred.

RATIONALE

No studies were identified that met the inclusion criteria for research question three. This is an evidence gap for further research to be conducted. 

Following a review of existing guidelines and in consultation with the CI Task Force, a consensus-based recommendation was developed. 

The National Institute for Health and Care Excellence (NICE) Hearing loss in adults: assessment and management guidelines were used to develop an initial draft as it was considered the most comprehensive [127]. However, it was considered appropriate that in all scenarios, if a person presents for the first time with any level of hearing loss or is experiencing hearing difficulties then a full audiological assessment should be conducted. Without a hearing test, it is unknown if the cause of hearing loss has been addressed. If the primary healthcare professional suspects the adult has sudden or rapid onset hearing loss, then referral to an emergency department or ENT specialist for additional diagnostic assessment is recommended. 

For more detailed information on the development of this recommendation, please see the Technical Report.

EVIDENCE SUMMARY

No studies were identified that met the inclusion criteria for research question three. This is an evidence gap for further research to be conducted.

HEARING HEALTHCARE SPECIALIST EVALUATION

Cochlear implants are suitable for many adults with severe to profound sensorineural hearing loss [27]. Cochlear implants can enhance speech clarity, making it easier for individuals to understand speech in noisy environments as well as when talking on the phone or listening to music through headphones [27]. In a recent study, people with cochlear implants could understand sentences eight times better than they could previously with their hearing aids [147][146].

Being able to understand speech better, improves a person’s confidence in social situations, reducing the risk of social isolation and other hearing loss-related risk factors [28]. Furthermore, cochlear implants have been associated with lower rates of mild cognition cognitive disorders [113][114] and a 19% decrease in the risk of long-term cognitive decline, as indicated by a systematic review of hearing restorative devices, including both cochlear implants and hearing aids [115]. 

Despite the potential benefits of cochlear implants, less than 10% of eligible adults will receive one in their lifetime [27]. Remarkably, in the United States of America, only 3% of all patients with moderate to profound sensorineural hearing loss are referred for a cochlear implant evaluation [6]. This underutilisation is due, in part, to limited awareness of eligibility criteria and referral processes [6][20]. Consistent criteria for identifying candidates for cochlear implants is necessary to ensure all individuals have the opportunity to be assessed and receive the best available care.

RECOMMENDATION 4

RESEARCH QUESTION

Question 4 – In adults with any level of hearing loss, what criteria should be met by routine assessment tools (audiological and/or clinical) to determine referral for a complete cochlear implant evaluation?

  • What is the diagnostic accuracy for each of the routine assessment tools?

Question 5- In adults with hearing loss who may not meet the eligibility criteria for a cochlear implant, what is the optimal frequency of assessment for monitoring hearing loss and for re-assessing them to determine referral for a complete cochlear implant evaluation?

STRONG RECOMMENDATION

An adult with any level of hearing loss should be referred for cochlear implant evaluation if they meet the cochlear implant eligibility criteria of three frequency (500, 1000, 2000 Hz) pure-tone average (PTA) in the better ear that is equal to or greater than 60 dB HL (decibels hearing level), AND expresses difficulties with speech understanding in their everyday environment [29].

Any adult that meets the above cochlear implant eligibility criteria should be referred to a cochlear implant specialist for a complete cochlear implant evaluation and preoperative assessment.

GOOD PRACTICE STATEMENT

  • For a person who does not meet the cochlear implant eligibility criteria above and has unilateral severe to profound and moderate sloping to profound sensorineural hearing loss, hearing healthcare specialists could use a poorer ear PTA of greater than or equal to 80 dB HL at four frequencies (500, 1000, 2000, and 4000 Hz) for referral [154]. 
  • Until further evidence is available, hearing healthcare specialists should use their own discretion for when to refer a person with asymmetrical sensorineural hearing loss or unilateral severe to profound and moderate sloping to profound sensorineural hearing loss for cochlear implant evaluation.
  • Prior to conducting the assessment to refer for a complete cochlear implant evaluation and preoperative assessment, the hearing healthcare specialist should ensure that those adults who have hearing aids have them correctly fitted. If the person has a hearing aid, and: 
    • the hearing aid is fitted correctly, continue to assess for referral for a complete cochlear implant evaluation and preoperative assessment.
    • the hearing aid is incorrectly fitted or functioning sub-optimally, the hearing healthcare specialist should first re-fit the hearing aid, then assess for referral for a complete cochlear implant evaluation and preoperative assessment.
  • If the adult is not eligible for a cochlear implant after being referred for a complete cochlear implant evaluation and preoperative assessment, their hearing care and reassessment should be at the discretion of the cochlear implant team they were referred to.

EVIDENCE TO DECISION

BENEFITS AND HARMS
Substantial net benefits of the recommended alternative
The criteria to determine referral for a complete cochlear implant evaluation lacks a standard of care globally, and therefore, the comparison of benefits and harms of the recommendation with alternatives is not possible. Nonetheless, the moderate certainty of evidence suggests that the benefits of being referred for a complete cochlear implant evaluation and preoperative assessment are likely to outweigh any associated harms. However, it is important to note that due to global variability on speech perception assessments, the recommendation only incorporates the PTA measure of the Zwolan 2020 guidelines [29]. Following consultation with the CI Task Force, it was revealed that PTA is the key criterion in determining cochlear implant candidacy globally.

CERTAINTY OF THE EVIDENCE
Moderate
As per GRADE, the overall certainty of the evidence was high due to no serious risk of bias, imprecision, inconsistency, or indirectness. However, the certainty of evidence was downgraded as the recommendation only took into account the PTA criteria of the Zwolan 2020 guidelines [29]. This was due to the global variability in speech perception assessments, and consultation with the CI Task Force revealed that the PTA measure is a critical factor in determining cochlear implant candidacy on a global scale.

VALUES AND PREFERENCES
No substantial variability expected
There is no reason to suspect that adults with any level of hearing loss would reject routine assessments to determine referral for a complete cochlear implant evaluation. However, there may be some individuals who choose not to have an assessment due to financial constraints, personal preference, or access difficulties.

RESOURCES AND OTHER CONSIDERATIONS
Important issues, or potential issues not investigated
The use of routine assessments to determine a referral for a complete cochlear implant evaluation is not expected to disproportionately use or misuse resources in an audiological or clinical setting. However, a formal health economic analysis was not conducted as a part of this review.

RATIONALE

Seven studies that assess the diagnostic accuracy of assessment tools for cochlear implant candidacy in adults with any level of hearing loss were identified in the systematic literature review [29][30][31][32][33][34][116]. The assessment tools used across the included studies [30][31][32][33][34], except the 60/60 referral guideline evaluated by Lee 2022 and Zwolan 2020 [29][116] were considered to be too complex and resource intensive for any hearing health care specialist to carry out. These five studies [30][31][32][33][34] were also considered to be of low certainty of evidence due to the small sample size and/or a large range of sensitivity and specificity values. 

Lee 2022 and Zwolan 2020 [29][116] are retrospective studies of data from adults who underwent a cochlear implant candidacy evaluation in a population whose dominant language is English. The studies observed a sensitivity range between 62-96% and a specificity range between 66-75% when using a better ear PTA equal to or greater than 60 dB HL, and a better ear unaided monosyllabic word score less than or equal to 60% correct. However, the unaided monosyllabic word score does not yield the same accuracy in non-dominant English speakers and thus cannot be implemented internationally. Further consultation with the CI Task Force revealed that the PTA is the primary factor in determining a referral for a complete cochlear implant evaluation. Additionally, the specification of a word recognition criteria for each dominant language could be confounding due to global variability and therefore was not considered for the recommendation. Therefore, functional hearing ability and speech understanding in the adult’s daily environment was deemed to be more appropriate for inclusion in a global guideline.

Until further evidence is available, the recommendation is based on Lee 2022 [116], Zwolan 2020 [29], and expert opinion. The recommendation proposes self-reported difficulty hearing in everyday environments in conjunction with a better ear PTA greater or equal to 60 dB HL to ensure that a person who may be eligible for a cochlear implant is appropriately referred for a full cochlear implant evaluation.

For further information on the development of the recommendation, please see the Technical Report. 

STUDY CHARACTERISTICS
The two included studies (Lee 2022, Zwolan 2020) were both retrospective reviews of registry data from adults who had undergone cochlear implant candidacy evaluation (CICE) for referral to a complete cochlear implant evaluation. Participants’ ages ranged from 19 to 98 and sample sizes ranged from 248 to 415 (total 663 participants). These studies were found to be at some risk of bias due to a lack of information regarding blinding of the reference standard and index test, and the timing between the index test and reference standard.

RECOMMENDATION 5

CONSENSUS RECOMMENDATION

If an adult with any level of hearing loss does not meet the cochlear implant eligibility criteria upon initial assessment, cochlear implant eligibility should be assessed every 1–3 years [7][22][26][129]. If upon reassessment the cochlear implant eligibility criteria is met, they should be referred to a cochlear implant specialist for a complete cochlear implant evaluation and preoperative assessment. However, if the person has sensorineural hearing loss (50 dB – 64 dB) or the adult experiences a significant change in their hearing ability, then they should be re-assessed every 6–12 months.

GOOD PRACTICE STATEMENT

  • To raise awareness of cochlear implants as a potential treatment option in the future, hearing healthcare specialists should be proactive in discussing cochlear implants with adults who have progressive hearing loss.
  • Hearing healthcare specialists should endeavour to convey that cochlear implantation is part of the hearing health continuum and not an end-stage treatment. Encouraging the exploration of cochlear implantation early may improve future uptake for adults with progressive hearing loss who do not currently meet the cochlear implant eligibility criteria.

EVIDENCE TO DECISION

VALUES AND PREFERENCES
No substantial variability expected
There is no plausible reason to suspect that adults with any level of hearing loss who do not meet cochlear implant candidacy criteria would not accept the monitoring and reassessment of their hearing as recommended. Some adults may not adhere or choose not to be reassessed due to potential financial burden, personal decision not to have a cochlear implant, and/or access issues.

RESOURCES AND OTHER CONSIDERATIONS
Important issues, or potential issues not investigated
The resource implications are uncertain. In some countries, there may be costs associated with the implementation of a reassessment for cochlear implant eligibility. However, a formal health economic analysis was not conducted as a part of this review.

RATIONALE

No studies were identified that met the inclusion criteria for research question five. A review of the existing guidelines found no evidence or recommendations pertaining to the reassessment and monitoring of individuals who do not meet cochlear implant eligibility criteria. Following consultation with the CI Task Force, a consensus-based recommendation was developed. 

The recommendation is focused on ensuring that adults with hearing loss who do not currently meet the cochlear implant candidacy criteria are not lost to follow-up in the future. Recent reports have observed that only 10% of adults who would benefit from cochlear implantation will actually receive one in their lifetime [27]. While the underutilisation of cochlear implants is the product of various factors, patient loss to follow-up likely accounts for a significant proportion of potential cochlear implant candidates going untreated.

A review of current guidelines has recommended that adults should have their hearing re-evaluated every 1–3 years in order to effectively monitor their hearing level. This reassessment is necessary to ensure accurate tracking of any changes in an adult’s hearing abilities [7][22][26][129].  The CI Task Force also revealed that those adults who have sensorineural hearing loss but do not meet the criteria should be reassessed more frequently. The recommended time frame for this indication was at least 6–12 months. Similarly, those adults who experience a significant change in their hearing ability or communication should also be reassessed within this time frame. 

For further information on the development of the recommendation, please see the Technical Report. 

ADDENDUM

Recommendations for a cochlear implant evaluation
This area is well served by existing guidelines.

The CI Task Force reviewed the following existing guidelines (all linked).

CI EVALUATION, SURGERY AND INTRA AND POST-OPERATIVE CARE

This area is well served by existing guidelines. The CI Task Force reviewed the following existing guidelines (all linked).

CI evaluation 

  1. AWMF Guideline S017/71 – S2k Guideline Cochlear Implantation German Society of Oto-Rhino-Laryngology, Head and Neck Surgery, 2020
  2. American Academy of Audiology CLINICAL PRACTICE GUIDELINE: COCHLEAR IMPLANTS
  3. Turton et al. 2020 Guidelines for Best Practice in the Audiological Management of Adults with Severe and Profound Hearing Loss
  4. FRENCH SOCIETY OF ENT (SFORL) GUIDELINES 2019. INDICATIONS FOR COCHLEAR IMPLANTATION IN ADULTS, European Annals of Otorhinolaryngology. Head and Neck Diseases.

 
CI surgery and intra and post-operative care 

  1. German Weißbuch (white paper) guidelines
  2. AWMF Guideline S017/73 – Implantable Hearing Aids – Association of German-speaking Audiologists, Neurootologists and Otologists of the German Society of Otorhinolaryngology, Head and Neck Surgery, 2017
  3. American Academy of Audiology CLINICAL PRACTICE GUIDELINE: COCHLEAR IMPLANTS

DEVICE PROGRAMMING AND REHABILITATION

Following cochlear implant activation after surgery, the recipient should receive implant programming and rehabilitation sessions to optimise performance [5]. 

Cochlear implant programming is necessary for users to hear sounds through the device [150]. Programming focuses on device optimisation, while rehabilitation is an active learning process that helps users make sense of the sounds they perceive. The definition of rehabilitation for cochlear implant users was developed in collaboration with CIICA and based on the WHO’s definition [153]. It refers to a set of interventions designed to optimise hearing in cochlear implant users to ensure that the person reaches the best quality of life at a physical, functional, social, emotional and economic level. The process of learning to hear with a cochlear implant is ongoing throughout the user’s lifetime and should include assistive devices, accessibility and technical assistance. However, a survey by CIICA found that users typically receive 12 or more rehabilitation or therapy services in the first year but no longer receive rehabilitation after that time [152]. Good mapping, which changes with progression, was also identified as a crucial component of rehabilitation [151].

Together, programming and rehabilitation help users achieve the best possible hearing outcomes and improve their quality of life [150].

RECOMMENDATION 6

RESEARCH QUESTION

Question 6 – For adult cochlear implant users with severe, profound or moderate sloping to profound sensorineural hearing loss, what is the most effective number of follow-up appointments one year post cochlear implantation to achieve optimal programming/stimulation levels?

Consensus recommendation

Initial activation and programming of adult cochlear implant users with severe, profound, or moderate sloping to profound sensorineural hearing loss should take place within the first 28 days post-surgery based on the person’s recovery and approval from the cochlear implant surgical team [35]. 

Post-activation, a cochlear implant user should have between 4–6 appointments within the first twelve months of cochlear implant use [35]. Of these, between 2–3 should be mapping appointments taking place during the first 3 months post-activation, with additional appointments in the first year being scheduled at the discretion of the cochlear implant surgical team.

GOOD PRACTICE STATEMENT

  • Device activation can take place from the day after surgery and up to four weeks thereafter. Considerations include the influence of resource utilisation, user anxiety around device function and loss of residual hearing, and post-implant health status. 
  • Additional programming sessions should be scheduled if certain changes in the person’s auditory responsiveness or speech production occur. These changes include, but are not limited to: 
    • Changes in auditory discrimination
    • Increased request for repetition 
    • Omission of sounds
    • Prolongation of vowels 
    • Change in vocal quality or volume 
    • Intermittency 
    • Fluctuation in hearing with device 
    • Balance issues 
    • Head trauma 
    • Infection or other medical concerns for the cochlear implant site
    • Anxiety
    • Depression
    • Cognitive impairment
    • Non-auditory stimulation
    • Sub-optimal hearing levels/progression
    • Technology updates

EVIDENCE TO DECISION

VALUES AND PREFERENCES
No substantial variability expected
There is no plausible reason to suspect that cochlear implant users would not accept the recommendations of optimal programming frequency. However, some adult users may choose not to undergo reassessment due to financial constraints, personal decisions or issues related to access.

RATIONALE

No studies were identified that met the inclusion criteria for research question six. Following a review of existing guidelines and in consultation with the CI Task Force, a consensus-based recommendation was developed. 

Existing guidelines provided insight to inform the current recommendation. The American Academy of Audiology proposed a specific follow-up schedule of at least six appointments in the first twelve months. The recommendation proposed a prescription of appointments starting with the initial activation appointment taking place one to four weeks post-surgery. Follow-up appointments then took place at one week, one month, three months, six months, and twelve months post-activation [35]. Additionally, recent the Delphi consensus guidelines found evidence suggesting frequent programming and fitting assessments within the first six months with an expectation to reduce appointment frequency six months onwards. However, due to inconsistencies in existing guidelines, an individualised approach to programming for cochlear implant users in their first year of device use was recommended taking into account their unique stimulation needs [5]. Patient-centred care in cochlear implant programming and rehabilitation has been previously recommended and is considered an important factor in achieving positive hearing health outcomes by the CI Task Force and through consultation with CIICA [5][117].

To optimise speech perception, it is recommended that users should undergo between four to six programming appointments within the first year after their initial activation session. The CI Task Force feedback provided insight on the emphasis that is required to ensure that user preference and variability was represented appropriately. Additionally, this allows the cochlear implant user to become accustomed to the device and ensures that the upper and lower stimulation levels are programmed appropriately. The CI Task Force also expressed a need to highlight circumstances where additional appointments in the first twelve months would be required. As such, a good practice statement addressing scenarios where a cochlear implant user may need additional programming appointments was developed.

For further information on the development of the recommendation, please see the Technical Report.

RECOMMENDATION 7

RESEARCH QUESTION

Question 7 – For adult cochlear implant users with severe, profound or moderate sloping to profound sensorineural hearing loss, what are the essential components of an appropriate clinical pathway for rehabilitation after surgery?

Consensus recommendation

Cochlear implant rehabilitation for a user with severe to profound or moderate sloping to profound sensorineural hearing loss should be a multidisciplinary and person-centred approach. The essential members of the multidisciplinary cochlear implant team include:

  • ENT specialist specialised in cochlear implants
  • Audiologist if available in your country (or equivalent) 
  • Speech therapist

The multidisciplinary cochlear implant team may involve other specialties including:

  • Psychologist
  • Social worker
  • Neurologist
  • Radiologist
  • Geriatrician
  • Peer group support

The multidisciplinary cochlear implant team should consider initial rehabilitation (rehabilitation in the first year following cochlear implantation) and lifelong rehabilitation (ongoing rehabilitation after the first year of cochlear implantation). The cochlear implant user, their family and/or friends should collaboratively plan their cochlear implant rehabilitation with their multidisciplinary team.

Initial rehabilitation

The components of initial rehabilitation that should be considered include:

ENT specialist specialised in cochlear implants

  • Cochlear implant review or follow up should take place up to six times. Additional programming sessions should be scheduled if certain changes in the person’s auditory responsiveness or speech production occur.
  • Otoscopy (using a magnifying otoscope, ear microscope or ear endoscope) and if necessary 
  • a radiological examination, and/or 
  • a laboratory examination.

Audiologist if available in your country (or equivalent)

  • Initial programming of the device to optimise access to sound and patient comfort and performance.
  • Check implant site related to magnet strength.
  • Information and in-depth instruction in handling (care, maintenance, fault and error detection) of the cochlear implant system and in the use of available additional devices (e.g. telephone adapter, charger, additional microphone, induction or T-coil, etc.).
  • Bimodal and electroacoustic adjustment, if necessary.
  • Monitor aided listening performance overtime using formal free field (sound field) hearing tests and standards
  • Speech perception test in silence and in background noise.
  • Counselling regarding pairing, fitting and usage of mobile media devices (e.g., smartphone TV, iPad and laptop) and other assistive listening devices.
  • Training on repair strategies (i.e. basic device troubleshooting).

Speech therapist (or audiologist, if not available)

  • Auditory therapy including analytic and synthetic auditory training (with phonemes, words, sentences and text) at the level of detection, discrimination, identification and comprehension in different listening conditions (in quiet, noise, with visual support e.g. lip-reading) and without visual support, using different listening devices (live voice, radio, laptop, TV, external microphone etc.).
  • Training or instruction on the appropriate use and management of the sound processor and assistive listening devices.
  • Training on how to improve your communication skills in daily life (at home, work, during leisure time etc.). Identify when communication has failed and why.
  • Listening 1 to 1 and in (small) groups.
  • Music training.
  • Telephone training.

Lifelong rehabilitation 

The components of lifelong rehabilitation that should be considered include:

ENT specialist specialised in cochlear implants

  • Cochlear implant review or follow up every 3 years, unless otherwise indicated.

Audiologist if available in your country (or equivalent)

  • Ongoing programming of the device to optimise access to sound and patient comfort and performance.
  • Technical advice and evaluation of the functionality of the cochlear implant system.
  • Counselling and fitting of mobile media devices and other assistive listening devices.
  • Speech perception test in silence and in background noise online, if available.
  • Monitor aided listening performance over time online, if available.
  • Periodical adjustment and fine-tuning of processors including control of stimulation parameters.
  • Training on repair strategies (i.e. basic device troubleshooting).

Speech therapist (or audiologist, if not available)

  • Monitor progress on all rehabilitation topics.
  • Appropriate use and management of the cochlear implant sound processor and assistive listening devices.
  • Ongoing auditory therapy to train speech perception in difficult listening situations. For example, listening in group situations, from a distance, in noise and through the telephone.
  • Training on how to improve communication skills in daily life (e.g. at home, work and during leisure time). Identify when communication has failed and why.

Other components

Other components of both initial and lifelong rehabilitation that could be considered on a case-by-case basis include:

  • Counselling or psychological support.
  • Peer group support.
  • Social worker support for those who need extra support to live independently.

GOOD PRACTICE STATEMENT

  • Rehabilitation and expectations should be discussed with the cochlear implant user and their family and/or friends prior to cochlear implantation (person-centred care).
  • The family and/or friends of the cochlear implant user should be considered and invited to participate in rehabilitation.
  • All cochlear implant users should be encouraged to engage in self-care using available resources. The multidisciplinary cochlear implant team should provide all users with resources available in their country for self-care and those to be used with family and/or friends. Cochlear implant manufacturer’s support tools should also be offered. 
  • If available, traditional rehabilitation services in the office or remotely should be offered in conjunction with self-care.
  • Counselling or psychological support should be considered to support the user and their family and/or friends with regards to expectations, the rehabilitation procedures and their ongoing commitment to the rehabilitation program.
  • The multidisciplinary cochlear implant team should communicate and share information (with the cochlear implant user’s consent) to ensure adaption and to be able to monitor changes in the performance and success of the cochlear implant.
  • The cochlear implant user’s progress must be monitored throughout initial and lifelong rehabilitation.

EVIDENCE TO DECISION

BENEFITS AND HARMS
Substantial net benefits of the recommended alternative
The balance between benefits, harms and burdens are uncertain due to a lack of evidence identified. The potential harms include misuse of resources. However, a good rehabilitation program develops the person’s ability to detect, imitate and associate meaning with the sounds of spoken language. It is thus anticipated that a comprehensive rehabilitation program for a user will outweigh any harms that may be associated with a rehabilitation program.

VALUES AND PREFERENCES
No substantial variability expected
There is no plausible reason to suspect that the cochlear implant user would not accept the rehabilitation program recommended and tailored to them by their multidisciplinary cochlear implant care team. The cochlear implant user and family preference should also be considered when providing cognitive rehabilitation. Some adults may not have access to or choose not to undertake some rehabilitation components because of individual circumstances, financial burden, and/or access issues.
Self-rehabilitation via online resources should always be encouraged.

RESOURCES AND OTHER CONSIDERATIONS
Important issues, or potential issues not investigated
The resource implications are uncertain. In some countries, there may be costs associated with the implementation of all or some of the components of the cochlear implant user’s rehabilitation program. However, a formal health economic analysis was not conducted as a part of this review.
Some adults may also not have access to traditional rehabilitation services either in the office or remotely.

RATIONALE

Four studies were identified that met the inclusion criteria for research question seven. However, the interventions were either very broad (i.e. did not describe the actual rehabilitation program in detail) or were investigative (e.g. amphetamine). These studies did not provide adequate or meaningful evidence to form an appropriate recommendation. A review of existing guidelines and identification of lower levels of evidence (e.g. case studies) was therefore undertaken to develop a consensus-based recommendation. 

No studies considered lower level of evidence (e.g. case studies) were identified. There were also no clear and consistent guidelines on best practices for rehabilitation after cochlear implantation. Based on available guidelines – more specifically the German Weißbuch and the German Society of Oto-Rhino-Laryngology guidelines as they were considered the most comprehensive [124][122]  – the components of rehabilitation that the multidisciplinary cochlear implant team members should consider have been proposed. Until further evidence is available, the specific programme should be tailored to the individual.

For further information on the development of the recommendation, please see the Technical Report.

PATIENT OUTCOMES AND MEASURES

When evaluating the success of cochlear implantation, patient-reported outcomes should be prioritised to ensure that the treatment is providing significant benefits that are important to the individual. Speech recognition has traditionally been the primary outcome measure in the past [39], however, other user-reported outcomes such as social wellbeing and general quality of life may be more important to cochlear implant users. 

Importantly there does not appear to be a strong relationship between speech recognition ability and patient self-report [45][46][47]. There may be two reasons for this difference:

  1. The complex communication, social and emotional situations that cochlear implant users experience may not be fully represented by word or sentence recognition alone.
  2. The manner in which cochlear implantation improves quality of life likely extends well beyond improvements in speech recognition. 

Although what is meaningful to cochlear implant users may differ based on their personal preferences and level of hearing loss, it is important to evaluate outcomes to compare various hearing loss interventions and communicate to newly diagnosed individuals the significance of cochlear implants in a way that resonates with them.

We also acknowledge the broader impacts of cochlear implants including the potential benefits to the families and/or friends of cochlear implant users and the improvements in caregiver quality of life [112], however, outcome measures for such stakeholders are beyond the scope of these guidelines. 

RECOMMENDATION 8

RESEARCH QUESTION

Question 8 – For adult cochlear implant users with severe, profound or moderate sloping to profound sensorineural hearing loss, which outcome measures are most meaningful to people to assess for improvement with a cochlear implant?

Consensus recommendation

Two outcomes were identified as most meaningful when evaluating improvement post-implantation in adult cochlear implant users with severe, profound or moderate sloping to profound sensorineural hearing loss. As such, audiologists if available in your country (or equivalent) should evaluate:

  • Hearing-specific quality of life (including social-emotional functioning and wellbeing)
  • Speech perception (particularly in noise)

GOOD PRACTICE STATEMENT

No good practice statements for Question 8.

EVIDENCE TO DECISION

BENEFITS AND HARMS
Substantial net benefits of the recommended alternative
The balance between benefits, harms, and burdens are uncertain due to a lack of evidence identified. The recommendation was however formulated based on user experience via CIICA. The benefit of evaluating the outcomes identified thus outweighs the harms of not evaluating the outcomes identified.

CERTAINTY OF THE EVIDENCE
Moderate
The systematic review did not identify any relevant evidence. As such, the recommendation is not developed with an evidence-based framework but informed through a consensus process involving previous guidelines and expert opinion from CIICA, the CI Task Force, and the co-chairs.
As the recommendation was developed predominately with feedback from a consensus process, it is very likely that the recommendation will not change if evidence becomes available.

VALUES AND PREFERENCES
No substantial variability expected
It is not expected that adult cochlear implant users with severe, profound or moderate sloping to profound sensorineural hearing loss would object to the use of cochlear implant-specific quality of life as the most meaningful measure for evaluating the effectiveness of the implant in improving their lives. However, it is acknowledged that some cochlear implant users may have different priorities in terms of the outcomes they value, depending on their stage of life and individual circumstances.

RESOURCES AND OTHER CONSIDERATIONS
Important issues, or potential issues not investigated
The resource implications are uncertain. In some countries, there may be costs associated with the additional time required to measure outcomes for adult cochlear implant users with severe, profound or moderate sloping to profound sensorineural hearing loss. However, a formal health economic analysis was not conducted as a part of this review.

RATIONALE

No studies were identified that met the inclusion criteria for research question eight. What is meaningful to cochlear implant users may differ based on their personal preferences and level of hearing loss. However, it is important to evaluate outcomes to compare various hearing loss interventions and communicate to newly diagnosed individuals the significance of cochlear implants in a way that resonates with them.

Cochlear implant users via the CIICA were consulted and a consensus-based recommendation was developed. For cochlear implant users, the most important outcome was quality of life including emotional functioning/wellbeing. 

For further information on the development of the recommendation, please see the Technical Report. 

EVIDENCE SUMMARY

No studies were identified that met the inclusion criteria for research question eight. This is an evidence gap for further research to be conducted.

RECOMMENDATION 9

RESEARCH QUESTION

Question 9 – For adult cochlear implant users with severe, profound or moderate sloping to profound sensorineural hearing loss, what measurement tools and/or questionnaires (e.g. speech tests, QoL questionnaires) should be utilised to measure patient outcomes?

    • How and when should professionals use the measurement tools and/or questionnaires?

Consensus recommendation

Two measurement tools should be used to evaluate the outcomes most meaningful to a person when evaluating improvement post-implantation in cochlear implant users with severe, profound or moderate sloping to profound sensorineural hearing loss. As such, audiologists if available in your country (or equivalent) should use:

  1. The Nijmegen Cochlear Implant Questionnaire (NCIQ) [43] or the Cochlear Implant-Quality of Life (CI-QoL) (global version at a minimum) to evaluate hearing-specific quality of life in adult cochlear implant users with severe, profound, or moderate sloping to profound sensorineural hearing loss. If the NCIQ or CI-QoL are not validated in the cochlear implant user’s dominant language, another validated QoL measure may be used.
  2. Validated communication measures including speech perception tests in the dominant language of the adult cochlear implant user by using words and/or sentences in quiet and noise.

The NCIQ or CI-QoL and speech perception measures should be administered before cochlear implantation to establish an individual’s baseline and then again at least once 6-12 months after the cochlear implant is activated to measure personal progress.

GOOD PRACTICE STATEMENT

  • If resources allow, the NCIQ and speech perception tests could be administered 3, 6, and 12 months after cochlear implantation [41] and re-evaluated annually after implantation [37]. 
  • If a cochlear implant user expresses concern about their experience with their cochlear implant, the NCIQ and speech perception test could be re-administered. 
  • Before administering the NCIQ and speech perception tests, the purpose of these evaluations should be explained to the cochlear implant user and/or their family and friends. 
  • Speech perception tests should be in the cochlear implant user’s dominant language.
  • Hearing healthcare specialists should prioritise using the data gathered to inform rehabilitation efforts, including monitoring device functioning and programming. 
  • If there is a decrease in a cochlear implant user’s outcomes, appropriate care and support should be prioritised. This may include revision of cochlear implant programming, monitoring device functioning, and rehabilitation efforts.
  • The NCIQ and speech perception tests should be administered more frequently if there is a marked decrease in an individual’s score.

EVIDENCE TO DECISION

BENEFITS AND HARMS
Substantial net benefits of the recommended alternative
The balance between benefits, harms, and burdens is uncertain due to a lack of evidence identified. The recommendation was formulated based on user experience via consultation with CIICA. Therefore it is expected that the benefit of evaluating the outcomes identified outweighs the harms of not evaluating the outcomes identified.

CERTAINTY OF EVIDENCE
Low
The recommendation was developed through a consensus process involving a review of previously published guidelines and expert opinion from CIICA, the CI Task Force and co-chairs. A systematic review of the literature was used to validate and support the consensus recommendation.
As the recommendation was developed predominantly with feedback from a consensus process, it is likely that the recommendation with not change if evidence becomes available.

VALUES AND PREFERENCES
No substantial variability expected
It is not expected that adult cochlear implant users with severe, profound or moderate sloping to profound sensorineural hearing loss would object to the use of a hearing-specific quality of life questionnaire as the most useful tool to measure the effectiveness of the implant in improving their lives nor the evaluation of speech perception in quiet and in noise. Similarly, it is not expected that hearing specialists would object to the administration of such tools for adult cochlear implant users.

RESOURCES AND OTHER CONSIDERATIONS
Important issues, or potential issues not investigated
The resource implications are uncertain. In some countries, there may be costs associated with the additional time required to measure outcomes for adult cochlear implant users with severe, profound or moderate sloping to profound sensorineural hearing loss. However, a formal health economic analysis was not conducted as part of this review.

RATIONALE

Review of global guidelines and recommendations (see sections D8.1.1 to D8.1.8 of the Technical Report) provides limited insight into which specific measurement tools and/or questionnaires should be used to measure outcomes that are meaningful to cochlear implant users. Research also highlights the mismatch between general quality of life questionnaires and the cochlear implant experience [39][42]. Nevertheless, the German Weißbuch guidelines [37] outline a protocol for quality assurance in the field of cochlear implant care where the 60-item Nijmegen Cochlear Implant Questionnaire (NCIQ) is used to assess cochlear implant user outcomes.

The NCIQ was developed as a disease-specific measurement tool to assess both speech and quality of life for cochlear implant users [40]. It has three domains (physical, social, and psychological) and six subdomains [40][43], including:

  • Basic sound perception
  • Advanced sound perception 
  • Speech production 
  • Self-esteem
  • Activity
  • Social interactions.

Its use has been validated cross-culturally and the tool is available in English, Chinese, Spanish, Italian, Portuguese, and Turkish [40].

Its routine use in existing clinical practice as per the German Weißbuch guidelines [124] was further supported by the number of RCTs identified in the literature that also reference the NCIQ. 13 out of 45 of the identified studies, approximately 29%, used the NCIQ to assess cochlear implant user outcomes. Its use was equal to the Health Utilities Index (HUI), another assessment tool that measures global quality of life outcomes [36][39]. However, the literature definitively recommends that disease-specific tools should be used in the context of cochlear implant users, to capture the experience of cochlear implant users sensitively and accurately [39][42].

The NCIQ was also featured in a systematic review of outcome domains and instruments which sought to inform the evidence base for those seeking to restore bilateral and binaural hearing in adults with unilateral severe to profound sensorineural hearing loss [38]. Its cross-cultural validation and translation into various languages including English, Chinese, Spanish, Italian, Portuguese, and Turkish is also highly useful in the creation of these guidelines and their global implementation [40].

Similarly, the Cochlear Implant-Quality of Life (CI-QoL) questionnaire was suggested for its completeness and patient-centred creation. Its use was particularly endorsed by CI Task Force members from the Canadian/American region. 

HTANALYSTS communicated with the author of the CI-QoL, Dr. Theodore McRackan, who confirmed the CI-QoL was available and validated in multiple languages, including English, Hebrew, Arabic, French, German, and Mandarin [134][135][136][137][138][139][140]. The questionnaire is also currently in the process of cross-cultural validation into Danish, Turkish, Malay, and Afrikaans.

For further information on the development of the recommendation, please see the Technical Report.

PRACTICAL INFO

Please follow the links below to find the NCIQ in its available languages:

Please follow the link below and follow the prompts to find the CI-QoL Global in its available languages (English, German, French, Hebrew, Arabic, Mandarin):

Please note, updates are currently being made to the link below. All versions and languages of the CI-QOL Global should be available be the end of February 2023.

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Best Practice Recommendations from the International Consensus Papers

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References
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