Download PDF
CC BY-NC-ND 4.0 · Semin Hear 2021; 42(04): 331-341
DOI: 10.1055/s-0041-1739283
Review Article

Determining Cochlear Implant Candidacy in Adults: Limitations, Expansions, and Opportunities for Improvement

Teresa A. Zwolan
1   Department of Otolaryngology – Head and Neck Surgery, Michigan Medicine, Ann Arbor, Michigan
,
Gregory Basura
1   Department of Otolaryngology – Head and Neck Surgery, Michigan Medicine, Ann Arbor, Michigan
› Author Affiliations
› Further Information
Also available at
   Permissions and Reprints

Abstract

The safety, efficacy, and success of cochlear implants (CIs) are well established and have led to changes in criteria used by clinicians to determine who should receive a CI. Such changes in clinical decision-making have out-paced the slower-occurring changes that have taken place with regulatory bodies' and insurers' indications. We review the historical development of indications for CIs, including those of the U.S. Food and Drug Administration (FDA), Medicare, Medicaid, and private insurers. We report on expansion to include patients with greater residual hearing, such as those who receive Hybrid and EAS devices, and report on recent FDA approvals that place less emphasis on the patient's best-aided condition and greater emphasis on the ear to be treated. This includes expansion of CIs to patients with single-side deafness and asymmetric hearing loss. We review changes in the test materials used to determine candidacy, including transition from sentences in quiet to sentences in noise to the recent use of monosyllabic words and cognitive screening measures. Importantly, we discuss the recent trend to recommend CIs despite a patient not meeting FDA or insurers' indications (a practice known as “off-label”), which serves as attestation that current indications need to be updated.

Keywords

cochlear implant candidacy - indications - speech recognition - FDA approval


Publication History

Article published online:
09 December 2021

© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

Thieme Medical Publishers, Inc.
333 Seventh Avenue, 18th Floor, New York, NY 10001, USA

 

  • References

  • 1 Van Norman GA. Drugs, devices, and the FDA: Part 2: An overview of approval processes: FDA approval of medical devices. JACC Basic Transl Sci 2016; 1 (04) 277-287
    CrossrefPubMedGoogle Scholar
  • 2 Fargen KM, Frei D, Fiorella D. et al. The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation?. J Neurointerv Surg 2013; 5 (04) 269-275
    CrossrefPubMedGoogle Scholar
  • 3 Roland Jr JT, Gantz BJ, Waltzman SB, Parkinson AJ. Multicenter Clinical Trial Group. United States multicenter clinical trial of the cochlear nucleus hybrid implant system. Laryngoscope 2016; 126 (01) 175-181
    CrossrefPubMedGoogle Scholar
  • 4 Pillsbury III HC, Dillon MT, Buchman CA. et al. Multicenter US clinical trial with an electric-acoustic stimulation (EAS) system in adults: final outcomes. Otol Neurotol 2018; 39 (03) 299-305
    CrossrefPubMedGoogle Scholar
  • 5 Gifford RH, Dorman MF, Shallop JK, Sydlowski SA. Evidence for the expansion of adult cochlear implant candidacy. Ear Hear 2010; 31 (02) 186-194
    CrossrefPubMedGoogle Scholar
  • 6 Hinder D, Linder TE, Schlegel-Wagner C, Candreia C. Benefit of bimodal stimulation with cochlear implant and hearing aid in elderly patients. [in German] Laryngorhinootologie 2017; 96 (07) 456-460
    Article in Thieme ConnectPubMedGoogle Scholar
  • 7 Devocht EMJ, Janssen AML, Chalupper J, Stokroos RJ, Kingma H, George ELJ. Self-assessment of unilateral and bimodal cochlear implant experiences in daily life. PLoS One 2020; 15 (12) e0242871
    CrossrefPubMedGoogle Scholar
  • 8 Mancini P, Dincer D'Alessandro H, Portanova G. et al. Bimodal cochlear implantation in elderly patients. Int J Audiol 2021; 60 (06) 469-478
    CrossrefPubMedGoogle Scholar
  • 9 Gifford R, Navarro C, Macy P, Blair L. FDA candidacy for cochlear implantation. In: Gifford R. ed. Cochlear Implant Patient Assessment, Evaluation of Candidacy, Performance and Outcomes. 2nd ed.. San Diego: Plural Publishing; 2020: 1-11
    Google Scholar
  • 10 U.S. Food and Drug Administration Information Sheet: “Off-Label” and Investigational Use of Marketed Drugs, Biologics, and Medical Devices. Guidance for Institutional Review Boards and Clinical Investigators. Content current as of May 5, 2020. Accessed July 21, 2021 at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/label-and-investigational-use-marketed-drugs-biologics-and-medical-devices
    PubMedGoogle Scholar
  • 11 Carlson ML, Sladen DP, Gurgel RK, Tombers NM, Lohse CM, Driscoll CL. Survey of the American Neurotology Society on Cochlear Implantation: Part 1, Candidacy assessment and expanding indications. Otol Neurotol 2018; 39 (01) e12-e19
    CrossrefPubMedGoogle Scholar
  • 12 Chambers JD, May KE, Neumann PJ. Medicare covers the majority of FDA-approved devices and Part B drugs, but restrictions and discrepancies remain. Health Aff (Millwood) 2013; 32 (06) 1109-1115
    CrossrefPubMedGoogle Scholar
  • 13 CMS.gov. Decision Memo for Cochlear Implantation (CAG-00107N). Accessed July 21, 2021 at: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=134#:~:text=Cochlear%20implants%20were%20first%20covered,%2C%20dated%20June%2030%2C%201986
    PubMedGoogle Scholar
  • 14 U.S. Department of Health & Human Services, National Institutes of Health, NIH Consensus Development Program Archive. Cochlear Implants in Adults and Children. Consensus Development Conference Statement. May 15–17, 1995. Accessed July 21, 2021 at: https://consensus.nih.gov/1995/1995cochlearimplants100html.htm
    PubMedGoogle Scholar
  • 15 Zwolan TA, Kallogjeri D, Firszt JB, Buchman CA. Assessment of cochlear implants for adult Medicare beneficiaries aged 65 years or older who meet expanded indications of open-set sentence recognition: a multicenter nonrandomized clinical trial. JAMA Otolaryngol Head Neck Surg 2020; 146 (10) 933-941
    CrossrefPubMedGoogle Scholar
  • 16 Sorkin D, Thomas MA. Cochlear Implantation: Health insurance and other possible ways of gaining Coverage. American Cochlear Implant Alliance (ACIA). Accessed July 21, 2021 at: https://www.acialliance.org/page/HealthIns
    PubMedGoogle Scholar
  • 17 Sorkin DL. Impact of Medicaid on cochlear implant access. Otol Neurotol 2019; 40 (03) e336-e341
    CrossrefPubMedGoogle Scholar
  • 18 Fifer RC, Stach BA, Jerger JF. Evaluation of the minimal auditory capabilities (MAC) test in prelingual and postlingual hearing-impaired adults. Ear Hear 1984; 5 (02) 87-90
    CrossrefPubMedGoogle Scholar
  • 19 Owens E, Kessler DK, Raggio MW, Schubert ED. Analysis and revision of the minimal auditory capabilities (MAC) battery. Ear Hear 1985; 6 (06) 280-290
    CrossrefPubMedGoogle Scholar
  • 20 Auditec, Inc.. Minimal Auditory Capabilities (MAC) September 22, 2015. Accessed July 21, 2021 at: https://auditec.com/2015/09/22/minimal-auditory-capabilities-mac
    PubMedGoogle Scholar
  • 21 Luxford WM. Ad Hoc Subcommittee of the Committee on Hearing and Equilibrium of the American Academy of Otolaryngology-Head and Neck Surgery. Minimum speech test battery for postlingually deafened adult cochlear implant patients. Otolaryngol Head Neck Surg 2001; 124 (02) 125-126
    CrossrefPubMedGoogle Scholar
  • 22 Gifford R. Adult cochlear implant candidate selection. In: Gifford R. ed. Cochlear Implant Patient Assessment, Evaluation of Candidacy, Performance and Outcomes. 2nd ed.. San Diego: Plural Publishing; 2020: 13-36
    Google Scholar
  • 23 Peterson GE, Lehiste I. Revised CNC lists for auditory tests. J Speech Hear Disord 1962; 27: 62-70
    CrossrefPubMedGoogle Scholar
  • 24 Nilsson M, Soli SD, Sullivan JA. Development of the Hearing in Noise Test for the measurement of speech reception thresholds in quiet and in noise. J Acoust Soc Am 1994; 95 (02) 1085-1099
    CrossrefPubMedGoogle Scholar
  • 25 Spahr AJ, Dorman MF, Litvak LM. et al. Development and validation of the AzBio sentence lists. Ear Hear 2012; 33 (01) 112-117
    CrossrefPubMedGoogle Scholar
  • 26 Etymotic, Inc.. BKB-SIN TM Speech-in-Noise Test. Accessed July 21, 2021 at: www.auditorypotential.com/MSTBfiles/MSTBManual2011-06-20%20.pdf
    PubMedGoogle Scholar
  • 27 Prentiss S, Snapp H, Zwolan T. Audiology practices in the preoperative evaluation and management of adult cochlear implant candidates. JAMA Otolaryngol Head Neck Surg 2020; 146 (02) 136-142
    CrossrefPubMedGoogle Scholar
  • 28 Gifford RH, Shallop JK, Peterson AM. Speech recognition materials and ceiling effects: considerations for cochlear implant programs. Audiol Neurotol 2008; 13 (03) 193-205
    CrossrefPubMedGoogle Scholar
  • 29 Moberly AC, Castellanos I, Mattingly JK. Neurocognitive factors contributing to cochlear implant candidacy. Otol Neurotol 2018; 39 (10) e1010-e1018
    CrossrefPubMedGoogle Scholar
  • 30 Sladen DP, Gifford RH, Haynes D. et al. Evaluation of a revised indication for determining adult cochlear implant candidacy. Laryngoscope 2017; 127 (10) 2368-2374
    CrossrefPubMedGoogle Scholar
  • 31 Wick CC, Kallogjeri D, McJunkin JL. et al; CI532 Study Group. Hearing and quality-of-life outcomes after cochlear implantation in adult hearing aid users 65 years or older: a secondary analysis of a nonrandomized clinical trial. JAMA Otolaryngol Head Neck Surg 2020; 146 (10) 925-932
    CrossrefPubMedGoogle Scholar
  • 32 Perkins E, Dietrich MS, Manzoor N. et al. Further evidence for the expansion of adult cochlear implant candidacy criteria. Otol Neurotol 2021; 42 (06) 815-823
    CrossrefPubMedGoogle Scholar
  • 33 Amoodi HA, Mick PT, Shipp DV. et al. Results with cochlear implantation in adults with speech recognition scores exceeding current criteria. Otol Neurotol 2012; 33 (01) 6-12
    CrossrefPubMedGoogle Scholar
  • 34 Birman CS, Sanli H. Cochlear implant outcomes in patients with severe compared with profound hearing loss. Otol Neurotol 2020; 41 (04) e458-e463
    CrossrefPubMedGoogle Scholar
  • 35 Dowell RC. The case for earlier cochlear implantation in postlingually deaf adults. Int J Audiol 2016; 55 (Suppl. 02) S51-S56
    CrossrefPubMedGoogle Scholar
  • 36 Vickers D, Kitterick P, Verschuur C. et al. Issues in cochlear implant candidacy. Cochlear Implants Int 2016; 17 (Suppl. 01) 1-2
    CrossrefPubMedGoogle Scholar
  • 37 Varadarajan VV, Sydlowski SA, Li MM, Anne S, Adunka OF. Evolving criteria for adult and pediatric cochlear implantation. Ear Nose Throat J 2021; 100 (01) 31-37
    CrossrefPubMedGoogle Scholar
  • 38 Sorkin DL, Buchman CA. Cochlear implant access in six developed countries. Otol Neurotol 2016; 37 (02) e161-e164
    CrossrefPubMedGoogle Scholar
  • 39 Shen J, Anderson MC, Arehart KH, Souza PE. Using cognitive screening tests in audiology. Am J Audiol 2016; 25 (04) 319-331
    CrossrefPubMedGoogle Scholar
  • 40 Fakurnejad S, Vail D, Song Y, Alyono J, Blevins NH. Trends in age of cochlear implant recipients, and the impact on perioperative complication rates. Otol Neurotol 2020; 41 (04) 438-443
    CrossrefPubMedGoogle Scholar
  • 41 Cosetti MK, Pinkston JB, Flores JM. et al. Neurocognitive testing and cochlear implantation: insights into performance in older adults. Clin Interv Aging 2016; 11: 603-613
    CrossrefPubMedGoogle Scholar
  • 42 Uchida Y, Sugiura S, Nishita Y, Saji N, Sone M, Ueda H. Age-related hearing loss and cognitive decline - the potential mechanisms linking the two. Auris Nasus Larynx 2019; 46 (01) 1-9
    CrossrefPubMedGoogle Scholar
  • 43 Beck D, Weinstein BE, Harvey M. Issues in cognitive screenings by audiologists. Hearing Review; January 21, 2016
    PubMedGoogle Scholar
  • 44 Souza P. The Importance of Cognitive Assessment in Audiology Practice. AudiologyOnline, February 11, 2019. Accessed July 21, 2021 at: https://www.audiologyonline.com/articles/20q-importance-cognitive-assessment-in-24433
    PubMedGoogle Scholar
  • 45 Holden LK, Finley CC, Firszt JB. et al. Factors affecting open-set word recognition in adults with cochlear implants. Ear Hear 2013; 34 (03) 342-360
    CrossrefPubMedGoogle Scholar
  • 46 Leung J, Wang NY, Yeagle JD. et al. Predictive models for cochlear implantation in elderly candidates. Arch Otolaryngol Head Neck Surg 2005; 131 (12) 1049-1054
    CrossrefPubMedGoogle Scholar
  • 47 Rubinstein JT, Parkinson WS, Tyler RS, Gantz BJ. Residual speech recognition and cochlear implant performance: effects of implantation criteria. Am J Otol 1999; 20 (04) 445-452
    PubMedGoogle Scholar