Expanded Indications in the Adult Cochlear Implant Population

NCT03236909 | Completed Results FDA Device

• 1 other identifier: G170111
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 5

Brief Summary

The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit hearing aids.

Conditions

Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (2)

• Change in Percent Correct on Word Recognition in Quiet in Implanted Ear

  CNC (Consonant Nucleus Consonant) word scores will be calculated as percent correct at baseline and at 6 months post-activation and reported as mean percentage-point improvement at 6 months post-activation compared to baseline.

  6 months post-activation

• Change in Percent Correct of Words Identified for Sentences in Noise in Implanted Ear

  AzBio sentence recognition in noise scores will be calculated as percent correct of words in each sentence at baseline and at 6 months post-activation and reported as mean percentage-point improvement at 6 months post-activation compared to baseline.

  6 months post-activation

Secondary Outcomes (4)

• Change in Global Score on Patient-reported Outcomes in Everyday Listening Condition

  6 months post-activation

• Number of Participants Experiencing an Adverse Device Effect (ADE)

  Through study completion, or at least 1 year, 4 months post-implantation

• Number of Participants With Residual Low-frequency Hearing

  6 months post-activation

• Change in Overall Score on Patient-reported Outcomes in Everyday Listening Condition

  6 months post-activation

Study Arms (1)

Single-arm

EXPERIMENTAL

Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant

Device: MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System

Interventions

MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System DEVICE

Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors.

Also known as: SYNCHRONY +FLEXSOFT, SYNCHRONY +FLEX28

Single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, 18 years of age or older at the time of implantation
• Moderate to profound hearing loss in the low frequencies and severe to profound hearing loss in the high frequencies, bilaterally as defined by: Low-frequency PTA (250, 500, and 1000 Hz) greater than 40 dB High-frequencies not better than 65 dB (3000 Hz - 8000 Hz)
• Sensorineural hearing loss, demonstrated by an air-bone gap of less than or equal to 10dB
• Limited benefit from appropriately fit hearing aids, defined by CNC word score in quiet of 60% or less in the ear to be implanted and 70% or less in the non-implanted ear
• CNC word score in quiet of greater than or equal to 10% in the ear to be implanted
• Evidence of appropriately fit hearing aids as determined by the audiologist
• Bilateral hearing aids should be considered standard of care, except in situations where the audiologist, physician, or potential subject determines that unilateral fit is optimal
• Hearing aid fit should be verified through accepted measures such as functional gain or real-ear verification
• If appropriately fit hearing aids have not been worn within the last year, a 30-day hearing aid trial must be completed prior to enrollment in the study
• Fluent in English
• No radiological contraindications
• Ability to undergo general anesthesia
• Appropriate motivation and expectation levels
• Stated willingness to comply with all study procedures for the duration of the study

You may not qualify if:

• Evidence that hearing loss is retrocochlear in origin
• Active middle ear infection
• Skin or scalp condition precluding use of external audio processor- Suspected cognitive impairment or organic brain dysfunction
• History of prior use of a hearing implant

Sponsors & Collaborators

• Med-El Corporation: lead

Study Sites (5)

University of Miami

Miami, Florida, 33136, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (18)

• Amoodi HA, Mick PT, Shipp DB, Friesen LM, Nedzelski JM, Chen JM, Lin VY. Results with cochlear implantation in adults with speech recognition scores exceeding current criteria. Otol Neurotol. 2012 Jan;33(1):6-12. doi: 10.1097/MAO.0b013e318239e5a1.

  PMID: 22090001 BACKGROUND

• Bassim MK, Buss E, Clark MS, Kolln KA, Pillsbury CH, Pillsbury HC 3rd, Buchman CA. MED-EL Combi40+ cochlear implantation in adults. Laryngoscope. 2005 Sep;115(9):1568-73. doi: 10.1097/01.mlg.0000171023.72680.95.

  PMID: 16148696 BACKGROUND

• Cox RM, Alexander GC. The abbreviated profile of hearing aid benefit. Ear Hear. 1995 Apr;16(2):176-86. doi: 10.1097/00003446-199504000-00005.

  PMID: 7789669 BACKGROUND

• Cullen RD, Higgins C, Buss E, Clark M, Pillsbury HC 3rd, Buchman CA. Cochlear implantation in patients with substantial residual hearing. Laryngoscope. 2004 Dec;114(12):2218-23. doi: 10.1097/01.mlg.0000149462.88327.7f.

  PMID: 15564849 BACKGROUND

• Dorman MF, Gifford RH, Spahr AJ, McKarns SA. The benefits of combining acoustic and electric stimulation for the recognition of speech, voice and melodies. Audiol Neurootol. 2008;13(2):105-12. doi: 10.1159/000111782. Epub 2007 Nov 29.

  PMID: 18057874 BACKGROUND

• Gantz BJ, Turner C, Gfeller KE. Acoustic plus electric speech processing: preliminary results of a multicenter clinical trial of the Iowa/Nucleus Hybrid implant. Audiol Neurootol. 2006;11 Suppl 1:63-8. doi: 10.1159/000095616. Epub 2006 Oct 6.

  PMID: 17063013 BACKGROUND

• Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. doi: 10.1080/14992020400050014.

  PMID: 15035561 BACKGROUND

• Gifford RH, Dorman MF, McKarns SA, Spahr AJ. Combined electric and contralateral acoustic hearing: word and sentence recognition with bimodal hearing. J Speech Lang Hear Res. 2007 Aug;50(4):835-43. doi: 10.1044/1092-4388(2007/058).

  PMID: 17675589 BACKGROUND

• Gifford RH, Dorman MF, Shallop JK, Sydlowski SA. Evidence for the expansion of adult cochlear implant candidacy. Ear Hear. 2010 Apr;31(2):186-94. doi: 10.1097/AUD.0b013e3181c6b831.

  PMID: 20071994 BACKGROUND

• Gifford RH, Dorman MF, Skarzynski H, Lorens A, Polak M, Driscoll CL, Roland P, Buchman CA. Cochlear implantation with hearing preservation yields significant benefit for speech recognition in complex listening environments. Ear Hear. 2013 Jul-Aug;34(4):413-25. doi: 10.1097/AUD.0b013e31827e8163.

  PMID: 23446225 BACKGROUND

• Gifford RH, Shallop JK, Peterson AM. Speech recognition materials and ceiling effects: considerations for cochlear implant programs. Audiol Neurootol. 2008;13(3):193-205. doi: 10.1159/000113510. Epub 2008 Jan 22.

  PMID: 18212519 BACKGROUND

• 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 Feb;95(2):1085-99. doi: 10.1121/1.408469.

  PMID: 8132902 BACKGROUND

• PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available.

  PMID: 14485785 BACKGROUND

• Skarzynski H, van de Heyning P, Agrawal S, Arauz SL, Atlas M, Baumgartner W, Caversaccio M, de Bodt M, Gavilan J, Godey B, Green K, Gstoettner W, Hagen R, Han DM, Kameswaran M, Karltorp E, Kompis M, Kuzovkov V, Lassaletta L, Levevre F, Li Y, Manikoth M, Martin J, Mlynski R, Mueller J, O'Driscoll M, Parnes L, Prentiss S, Pulibalathingal S, Raine CH, Rajan G, Rajeswaran R, Rivas JA, Rivas A, Skarzynski PH, Sprinzl G, Staecker H, Stephan K, Usami S, Yanov Y, Zernotti ME, Zimmermann K, Lorens A, Mertens G. Towards a consensus on a hearing preservation classification system. Acta Otolaryngol Suppl. 2013;(564):3-13. doi: 10.3109/00016489.2013.869059.

  PMID: 24328756 BACKGROUND

• Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549.

  PMID: 21829134 BACKGROUND

• Verschuur C, Hellier W, Teo C. An evaluation of hearing preservation outcomes in routine cochlear implant care: Implications for candidacy. Cochlear Implants Int. 2016 Apr;17 Suppl 1:62-5. doi: 10.1080/14670100.2016.1152007.

  PMID: 27099115 BACKGROUND

• Vickers D, De Raeve L, Graham J. International survey of cochlear implant candidacy. Cochlear Implants Int. 2016 Apr;17 Suppl 1:36-41. doi: 10.1080/14670100.2016.1155809.

  PMID: 27099109 BACKGROUND

• von Ilberg CA, Baumann U, Kiefer J, Tillein J, Adunka OF. Electric-acoustic stimulation of the auditory system: a review of the first decade. Audiol Neurootol. 2011;16 Suppl 2:1-30. doi: 10.1159/000327765. Epub 2011 May 24.

  PMID: 21606646 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Research Manager
• Organization: MED-EL Corporation

research.us@medel.com

888-633-3524

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 2, 2017
• Study Start: April 16, 2018
• Primary Completion: March 27, 2023
• Study Completion: March 27, 2023
• Last Updated: June 24, 2025
• Results First Posted: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (4)