Hearing Loss, SensorineuralNCT03236909
Expanded Indications in the Adult Cochlear Implant Population
A study testing MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System in people with Hearing Loss, Sensorineural, run by Med-El Corporation at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 16 Apr 2018to 27 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Miami
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt University
Nashville, Tennessee, 37232
About this study
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.
Read the detailed description
Fifty (50) subjects, 18 years of age and older, will be implanted across the United States and Canada. Subjects with moderate to profound bilateral sensorineural hearing loss will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System. .
Limited benefit from amplification is defined by test scores of 60% correct or less in the ear to be implanted (70% or less in the nonimplanted ear) on monosyllabic words in quiet. Subjects will be followed for twelve (12) months post-activation of the SONNETEAS Audio Processor.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant SystemDevice
Also called SYNCHRONY +FLEXSOFT, SYNCHRONY +FLEX28
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant Receives: Device: MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months post-activation
Secondary outcomes (4)
Change in Global Score on Patient-reported Outcomes in Everyday Listening Condition
APHAB (ABBREVIATED PROFILE OF HEARING AID BENEFIT) questionnaire will be used to assess subjective outcomes and reported as change in mean Global Score at 6 months post-activation compared to baseline. Letter responses from A to G on each question have a percent value, and the Global Score is an average percent value of all letters. A lower score shows less difficulty (better performance).
Measured: 6 months post-activation
Number of Participants Experiencing an Adverse Device Effect (ADE)
Adverse device effects will be collected for all participants through study completion and reported as the number of participants experiencing an ADE.
Measured: Through study completion, or at least 1 year, 4 months post-implantation
Number of Participants With Residual Low-frequency Hearing
HEARRING scale will be used to calculate the percent of hearing preservation for each subject by comparing average hearing thresholds from 125 to 1000 Hz at 6 months post-activation to the average at baseline.
Measured: 6 months post-activation
Change in Overall Score on Patient-reported Outcomes in Everyday Listening Condition
The SSQ (Spatial and Qualities of Hearing) questionnaire will be used to assess subjective outcomes and reported as change in mean Overall Score at 6 months post-activation compared to baseline. SSQ is scored on a 10-point Likert scale where 10 shows better listening skills/experiences than 0.
Measured: 6 months post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start16 Apr 2018
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Med-El Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236909
- Sponsor's protocol ID
- G170111
- Status last verified
- Jun 2025
- First submitted
- 28 Jul 2017
- Last updated
- 24 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22090001Bassim 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.
PubMed 16148696Cox RM, Alexander GC. The abbreviated profile of hearing aid benefit. Ear Hear. 1995 Apr;16(2):176-86. doi: 10.1097/00003446-199504000-00005.
PubMed 7789669Cullen 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.
PubMed 15564849Dorman 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.
PubMed 18057874Gantz 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.
PubMed 17063013Gatehouse 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.
PubMed 15035561Gifford 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).
PubMed 17675589Gifford 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.
PubMed 20071994Gifford 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.
PubMed 23446225Gifford 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.
PubMed 18212519Nilsson 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.
PubMed 8132902PETERSON 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.
PubMed 14485785Skarzynski 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.
PubMed 24328756Spahr 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.
PubMed 21829134
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Indications in the Adult Cochlear Implant Population
- ClinicalTrials.gov ID
- NCT03236909
- Acronym / sponsor ID
- G170111
- Conditions
- Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Med-El CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 2 Aug 2017 (actual)
- Results
- Posted 24 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fifty (50) subjects, 18 years of age and older, will be implanted across the United States and Canada. Subjects with moderate to profound bilateral sensorineural hearing loss will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System. .
Limited benefit from amplification is defined by test scores of 60% correct or less in the ear to be implanted (70% or less in the nonimplanted ear) on monosyllabic words in quiet. Subjects will be followed for twelve (12) months post-activation of the SONNETEAS Audio Processor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Device: MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant SystemSingle-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant SystemAlso: SYNCHRONY +FLEXSOFT, SYNCHRONY +FLEX28Subjects 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. | Device | Single-arm |
Primary outcome
Change in Percent Correct on Word Recognition in Quiet in Implanted Ear
Time frame: 6 months post-activation
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.
Change in Percent Correct of Words Identified for Sentences in Noise in Implanted Ear
Time frame: 6 months post-activation
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.
4 secondary outcomes
Change in Global Score on Patient-reported Outcomes in Everyday Listening Condition
Time frame: 6 months post-activation
Number of Participants Experiencing an Adverse Device Effect (ADE)
Time frame: Through study completion, or at least 1 year, 4 months post-implantation
Number of Participants With Residual Low-frequency Hearing
Time frame: 6 months post-activation
Change in Overall Score on Patient-reported Outcomes in Everyday Listening Condition
Time frame: 6 months post-activation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22090001Amoodi 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.
- Background: PubMed 16148696Bassim 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.
- Background: PubMed 7789669Cox RM, Alexander GC. The abbreviated profile of hearing aid benefit. Ear Hear. 1995 Apr;16(2):176-86. doi: 10.1097/00003446-199504000-00005.
- Background: PubMed 15564849Cullen 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.
- Background: PubMed 18057874Dorman 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.
- Background: PubMed 17063013Gantz 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.
- Background: PubMed 15035561Gatehouse 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.
- Background: PubMed 17675589Gifford 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).
- Background: PubMed 20071994Gifford 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.
- Background: PubMed 23446225Gifford 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.
- Background: PubMed 18212519Gifford 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.
- Background: PubMed 8132902Nilsson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System in people with Hearing Loss, Sensorineural, run by Med-El Corporation at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percent Correct on Word Recognition in Quiet in Implanted Ear (time frame: 6 months post-activation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03236909, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.