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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 has been through a period of public consultation from International Cochlear Implant Day, 25th February 2023 until the 31st May 2023. You are still able to provide comments and the Task Force warmly welcomes feedback from all members of the global healthcare community. 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. All feedback will be considered by the Task Force, to support their evaluation of the recommendations and good practice statements included in the guidelines.

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.

Introducing the Living Guidelines for Adult Cochlear Implantation
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. This is an interactive pdf with links, highlighting where the recommendations fit across the patient pathway. Click on each green circle to link to the recommendation via MAGICapp.

Download
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. 

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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.

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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.

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ADDENDUM

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].

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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. 

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PRACTICAL INFO

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[44]  Technical Report Appendix D-H.

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The living guidelines for adult cochlear implantation

The living guidelines for adult cochlear implantation

The Cochlear Implant International Community of Action (CIICA) have published a summary of guideline recommendations. Click here to download the PDF.

Best Practice Recommendations from the International Consensus Papers

View Here

References
1. Buchman et al. Unilateral Cochlear Implants for Severe, Profound, or Moderate Sloping to Profound Bilateral Sensorineural Hearing Loss A Systematic Review and Consensus Statements. 2. Sorkin, D. L. (2013). Cochlear implantation in the world’s largest medical device market: utilization and awareness of cochlear implants in the United States. Cochlear implants international, 14(sup1), S12-S4. 3. Van de Heyning, P., Gavilán, J., Godey, B., Hagen, R., Hagr, A., Kameswaran, M.,& Staecker, H. (2022). Worldwide variation in cochlear implant candidacy. Journal of International Advanced Otology, 18(3), 196-202.