Hearing Loss, UnilateralNCT06734039
Impact of Anatomy-Based Cochlear Implant Programming on Early Performance
A study testing Programming of cochlear implant audio processor frequency settings in people with Hearing Loss, Unilateral and Cochlear Implants, run by Med-El Corporation at 6 sites in United States.
Trial summary
The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users using electric-only stimulation in the implanted ear with normal hearing to moderately severe hearing loss in the opposite ear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Unilateral, Cochlear Implants, Hearing Loss, Sensorineural
- What is being tested?
- Programming of cochlear implant audio processor frequency settings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- 10 Nov 2025to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Subjects who do not meet one or more of the above-mentioned inclusion criteria are excluded from the study
- Subjects required to use a hearing aid per inclusion criteria who stop use of a hearing aid in the contralateral ear will be withdrawn at the time of discontinued hearing aid use
- Subjects who receive a cochlear implant in the contralateral ear prior to the 12-month interval
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
MED-EL Corporation
Durham, North Carolina, 27516
University of Iowa
Iowa City, Iowa, 52242
University of Kansas Medical Center
Kansas City, Kansas, 66160
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Impact of Anatomy-Based Frequency (ABF) Allocations on Early Performance Outcomes in MED-EL Cochlear Implant Recipients
The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users using electric-only stimulation in the implanted ear with normal hearing to moderately severe hearing loss in the opposite ear.
Read the detailed description
Participants will be randomized into a starting frequency setting at device activation or shortly after device activation for the first three months of device use. After 3 months listening experience, participants will be randomized into different frequency settings and tested before and after a period of listening experience. Participant outcomes for each of the multiple frequency settings will be evaluated using standard clinical speech testing and through questionnaires designed to capture information about patient sound quality and quality of life.
- Conditions
- Hearing Loss, Unilateral, Cochlear Implants, Hearing Loss, Sensorineural, Single-Sided Deafness (SSD), Asymmetric Hearing Loss
- Being tested
- Programming of cochlear implant audio processor frequency settings
- Keywords
- cochlear implant, Single-Sided Deafness
- Medical subject headings
- Hearing Loss, Unilateral, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programming of cochlear implant audio processor frequency settingsDevice
Also called anatomy-based fitting
Cochlear implant audio processor frequency settings will be adjusted within the clinical programming software
| Study group | Role | What they receive |
|---|---|---|
| Default Clinical Frequency Setting | Active comparator | The audio processor frequency setting will be programmed based on current frequency defaults in the clinical programming software Receives: Device: Programming of cochlear implant audio processor frequency settings |
| Default Anatomy-Based Fitting | Active comparator | The audio processor frequency setting will be programmed based on current anatomy-based fitting frequency defaults in the clinical programming software Receives: Device: Programming of cochlear implant audio processor frequency settings |
| Experimental Anatomy-Based Fitting 1 | Experimental | The audio processor frequency setting will be programmed using experimental settings for anatomy-based fitting using individual anatomical information obtained from analysis of post-operative imaging. Receives: Device: Programming of cochlear implant audio processor frequency settings |
| Experimental Anatomy-Based Fitting 2 | Experimental | The audio processor frequency setting will be programmed with experimental settings for anatomy-based fitting using individual anatomical information obtained from analysis of post-operative imaging. Receives: Device: Programming of cochlear implant audio processor frequency settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent correct on AzBio Sentences in Noise
The AzBio sentence test, consisting of lists of 20 sentences spoken by male and female talkers, will be tested in noise in three spatial listening conditions with after listening experience with each frequency setting. Listening conditions include co-located presentation of the target and noise, target presented with noise to the implanted ear, and target presented with noise to the opposite acoustic hearing ear. Outcomes will be reported as percent correct (%).
Measured: 3 to 7 months
Cochlear Implant Quality of Life - 35 Profile (CIQoL 35)
Subjects will complete a 35-item questionnaire with a total score ranging from 0-100% (higher score indicates a higher level of functional ability with a cochlear implant) regarding their subjective listening experience in 6 domains: communication, emotional, entertainment, environment, listening effort, social.
Measured: Enrollment to 7 months
Secondary outcomes (7)
Post-operative Audiogram
Unaided pure-tone audiometric thresholds will be tested for both ears. For patients with moderate to moderately severe hearing loss in the unimplanted ear, thresholds will also be tested in the best-aided condition.
Measured: Enrollment and 12 months
Percent Correct on Az Bio Sentences in Noise
The AzBio sentence test, consisting of lists of 20 sentences spoken by male and female talkers, will be tested in noise in three spatial listening conditions with after listening experience with each frequency setting. Listening conditions include co-located presentation of the target and noise, target presented with noise to the implanted ear, and target presented with noise to the opposite acoustic hearing ear. Outcomes will be reported as percent correct (%).
Measured: 12 months
Percent Correct on Consonant Nucleus Consonant (CNC) Words
The CNC test, consisting of 50 words scored as percent correct, will be tested in quiet after listening experience with each frequency setting for the implanted ear alone.
Measured: 3 to 12 months
Subjective feedback questionnaire
Subjects will complete a non-validated subjective questionnaire assessing their perceptual sound quality prior to and after listening experience with different frequency settings. The questionnaire utilizes multiple choice questions, a 5-point Likert scale, and open-ended questions intended to collect subject feedback.
Measured: Enrollment to 12 months
Psychoacoustic Testing of Sound Quality and Preference
Subjects will listen to speech and non-speech sounds will rate the quality of each sound on a 6-point Likert scale using different frequency settings. Subjects will then be asked to rank the different frequency settings relative to each other for quality and preference.
Measured: 7 months
Cochlear Implant Quality of Life- 35 Profile (CIQoL35)
Subjects will complete a 35-item questionnaire with a total score ranging from 0-100% (higher score indicates a higher level of functional ability with a cochlear implant) regarding their subjective listening experience in 6 domains: communication, emotional, entertainment, environment, listening effort, social.
Measured: 12 months
Decisional Regret Scale
A validated questionnaire using a 5-point Likert scale to assess decisional regret after cochlear implantation.
Measured: 3 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start10 Nov 2025
- Primary completionApr 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, UnilateralStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Med-El Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katelyn Glassman, AuD, Principal investigator, Med-El Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734039
- Sponsor's protocol ID
- US2401 MED-EL ABF
- Status last verified
- Mar 2026
- First submitted
- 5 Dec 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Shannon CM, Schvartz-Leyzac KC, Dubno JR, McRackan TR. Determinants of Cochlear Implant Satisfaction and Decisional Regret in Adult Cochlear Implant Users. Otol Neurotol. 2023 Dec 1;44(10):e722-e729. doi: 10.1097/MAO.0000000000004028. Epub 2023 Oct 19.
PubMed 37853774Sturm JJ, Ma C, McRackan TR, Schvartz-Leyzac KC. Frequency-to-Place Mismatch Impacts Cochlear Implant Quality of Life, But Not Speech Recognition. Laryngoscope. 2024 Jun;134(6):2898-2905. doi: 10.1002/lary.31264. Epub 2024 Jan 12.
PubMed 38214299Kurz A, Herrmann D, Muller-Graff FT, Voelker J, Hackenberg S, Rak K. Anatomy-based fitting improves speech perception in noise for cochlear implant recipients with single-sided deafness. Eur Arch Otorhinolaryngol. 2025 Jan;282(1):467-479. doi: 10.1007/s00405-024-08984-4. Epub 2024 Sep 19.
PubMed 39299967Fan X, Yang T, Fan Y, Song W, Gu W, Lu X, Chen Y, Chen X. Hearing outcomes following cochlear implantation with anatomic or default frequency mapping in postlingual deafness adults. Eur Arch Otorhinolaryngol. 2024 Feb;281(2):719-729. doi: 10.1007/s00405-023-08151-1. Epub 2023 Aug 7.
PubMed 37548704Kurz A, Herrmann D, Hagen R, Rak K. Using Anatomy-Based Fitting to Reduce Frequency-to-Place Mismatch in Experienced Bilateral Cochlear Implant Users: A Promising Concept. J Pers Med. 2023 Jul 8;13(7):1109. doi: 10.3390/jpm13071109.
PubMed 37511722Creff G, Lambert C, Coudert P, Pean V, Laurent S, Godey B. Comparison of Tonotopic and Default Frequency Fitting for Speech Understanding in Noise in New Cochlear Implantees: A Prospective, Randomized, Double-Blind, Cross-Over Study. Ear Hear. 2024 Jan-Feb 01;45(1):35-52. doi: 10.1097/AUD.0000000000001423. Epub 2023 Oct 12.
PubMed 37823850Dillon MT, Canfarotta MW, Buss E, Rooth MA, Richter ME, Overton AB, Roth NE, Dillon SM, Raymond JH, Young A, Pearson AC, Davis AG, Dedmon MM, Brown KD, O'Connell BP. Influence of Electric Frequency-to-Place Mismatches on the Early Speech Recognition Outcomes for Electric-Acoustic Stimulation Users. Am J Audiol. 2023 Mar;32(1):251-260. doi: 10.1044/2022_AJA-21-00254. Epub 2023 Feb 17.
PubMed 36800505Tan CT, Martin B, Svirsky MA. Pitch Matching between Electrical Stimulation of a Cochlear Implant and Acoustic Stimuli Presented to a Contralateral Ear with Residual Hearing. J Am Acad Audiol. 2017 Mar;28(3):187-199. doi: 10.3766/jaaa.15063.
PubMed 28277210Svirsky MA, Fitzgerald MB, Sagi E, Glassman EK. Bilateral cochlear implants with large asymmetries in electrode insertion depth: implications for the study of auditory plasticity. Acta Otolaryngol. 2015 Apr;135(4):354-63. doi: 10.3109/00016489.2014.1002052. Epub 2015 Feb 26.
PubMed 25719506Mertens G, Van de Heyning P, Vanderveken O, Topsakal V, Van Rompaey V. The smaller the frequency-to-place mismatch the better the hearing outcomes in cochlear implant recipients? Eur Arch Otorhinolaryngol. 2022 Apr;279(4):1875-1883. doi: 10.1007/s00405-021-06899-y. Epub 2021 Jun 15.
PubMed 34131770Canfarotta MW, Dillon MT, Buss E, Pillsbury HC, Brown KD, O'Connell BP. Frequency-to-Place Mismatch: Characterizing Variability and the Influence on Speech Perception Outcomes in Cochlear Implant Recipients. Ear Hear. 2020 Sep/Oct;41(5):1349-1361. doi: 10.1097/AUD.0000000000000864.
PubMed 32205726Goupell MJ, Noble JH, Phatak SA, Kolberg E, Cleary M, Stakhovskaya OA, Jensen KK, Hoa M, Kim HJ, Bernstein JGW. Computed-Tomography Estimates of Interaural Mismatch in Insertion Depth and Scalar Location in Bilateral Cochlear-Implant Users. Otol Neurotol. 2022 Jul 1;43(6):666-675. doi: 10.1097/MAO.0000000000003538.
PubMed 35761459Fitzgerald MB, Prosolovich K, Tan CT, Glassman EK, Svirsky MA. Self-Selection of Frequency Tables with Bilateral Mismatches in an Acoustic Simulation of a Cochlear Implant. J Am Acad Audiol. 2017 May;28(5):385-394. doi: 10.3766/jaaa.15077.
PubMed 28534729Fitzgerald MB, Sagi E, Jackson M, Shapiro WH, Roland JT Jr, Waltzman SB, Svirsky MA. Reimplantation of hybrid cochlear implant users with a full-length electrode after loss of residual hearing. Otol Neurotol. 2008 Feb;29(2):168-73. doi: 10.1097/mao.0b013e31815c4875.
PubMed 18165793Shannon RV. The relative importance of amplitude, temporal, and spectral cues for cochlear implant processor design. Am J Audiol. 2002 Dec;11(2):124-7. doi: 10.1044/1059-0889(2002/013).
PubMed 12691223
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anatomy-Based Frequency (ABF) Allocations on Early Performance Outcomes in MED-EL Cochlear Implant Recipients
- ClinicalTrials.gov ID
- NCT06734039
- Acronym / sponsor ID
- US2401 MED-EL ABF
- Conditions
- Hearing Loss, Unilateral, Cochlear Implants, Hearing Loss, Sensorineural, Single-Sided Deafness (SSD), Asymmetric Hearing Loss
- Keywords
- cochlear implant, Single-Sided Deafness
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Med-El CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
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 study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users using electric-only stimulation in the implanted ear with normal hearing to moderately severe hearing loss in the opposite ear.
Detailed description
Participants will be randomized into a starting frequency setting at device activation or shortly after device activation for the first three months of device use. After 3 months listening experience, participants will be randomized into different frequency settings and tested before and after a period of listening experience. Participant outcomes for each of the multiple frequency settings will be evaluated using standard clinical speech testing and through questionnaires designed to capture information about patient sound quality and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Default Clinical Frequency Setting | Active comparator | Device: Programming of cochlear implant audio processor frequency settingsThe audio processor frequency setting will be programmed based on current frequency defaults in the clinical programming software |
| Default Anatomy-Based Fitting | Active comparator | Device: Programming of cochlear implant audio processor frequency settingsThe audio processor frequency setting will be programmed based on current anatomy-based fitting frequency defaults in the clinical programming software |
| Experimental Anatomy-Based Fitting 1 | Experimental | Device: Programming of cochlear implant audio processor frequency settingsThe audio processor frequency setting will be programmed using experimental settings for anatomy-based fitting using individual anatomical information obtained from analysis of post-operative imaging. |
| Experimental Anatomy-Based Fitting 2 | Experimental | Device: Programming of cochlear implant audio processor frequency settingsThe audio processor frequency setting will be programmed with experimental settings for anatomy-based fitting using individual anatomical information obtained from analysis of post-operative imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Subjects who do not meet one or more of the above-mentioned inclusion criteria are excluded from the study
- Subjects required to use a hearing aid per inclusion criteria who stop use of a hearing aid in the contralateral ear will be withdrawn at the time of discontinued hearing aid use
- Subjects who receive a cochlear implant in the contralateral ear prior to the 12-month interval
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 |
|---|---|---|
| Programming of cochlear implant audio processor frequency settingsAlso: anatomy-based fittingCochlear implant audio processor frequency settings will be adjusted within the clinical programming software | Device | Default Anatomy-Based Fitting, Default Clinical Frequency Setting, Experimental Anatomy-Based Fitting 1, Experimental Anatomy-Based Fitting 2 |
Primary outcome
Percent correct on AzBio Sentences in Noise
Time frame: 3 to 7 months
The AzBio sentence test, consisting of lists of 20 sentences spoken by male and female talkers, will be tested in noise in three spatial listening conditions with after listening experience with each frequency setting. Listening conditions include co-located presentation of the target and noise, target presented with noise to the implanted ear, and target presented with noise to the opposite acoustic hearing ear. Outcomes will be reported as percent correct (%).
Cochlear Implant Quality of Life - 35 Profile (CIQoL 35)
Time frame: Enrollment to 7 months
Subjects will complete a 35-item questionnaire with a total score ranging from 0-100% (higher score indicates a higher level of functional ability with a cochlear implant) regarding their subjective listening experience in 6 domains: communication, emotional, entertainment, environment, listening effort, social.
7 secondary outcomes
Post-operative Audiogram
Time frame: Enrollment and 12 months
Percent Correct on Az Bio Sentences in Noise
Time frame: 12 months
Percent Correct on Consonant Nucleus Consonant (CNC) Words
Time frame: 3 to 12 months
Subjective feedback questionnaire
Time frame: Enrollment to 12 months
Psychoacoustic Testing of Sound Quality and Preference
Time frame: 7 months
Cochlear Implant Quality of Life- 35 Profile (CIQoL35)
Time frame: 12 months
Decisional Regret Scale
Time frame: 3 to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 37853774Shannon CM, Schvartz-Leyzac KC, Dubno JR, McRackan TR. Determinants of Cochlear Implant Satisfaction and Decisional Regret in Adult Cochlear Implant Users. Otol Neurotol. 2023 Dec 1;44(10):e722-e729. doi: 10.1097/MAO.0000000000004028. Epub 2023 Oct 19.
- Background: PubMed 38214299Sturm JJ, Ma C, McRackan TR, Schvartz-Leyzac KC. Frequency-to-Place Mismatch Impacts Cochlear Implant Quality of Life, But Not Speech Recognition. Laryngoscope. 2024 Jun;134(6):2898-2905. doi: 10.1002/lary.31264. Epub 2024 Jan 12.
- Background: PubMed 39299967Kurz A, Herrmann D, Muller-Graff FT, Voelker J, Hackenberg S, Rak K. Anatomy-based fitting improves speech perception in noise for cochlear implant recipients with single-sided deafness. Eur Arch Otorhinolaryngol. 2025 Jan;282(1):467-479. doi: 10.1007/s00405-024-08984-4. Epub 2024 Sep 19.
- Background: PubMed 37548704Fan X, Yang T, Fan Y, Song W, Gu W, Lu X, Chen Y, Chen X. Hearing outcomes following cochlear implantation with anatomic or default frequency mapping in postlingual deafness adults. Eur Arch Otorhinolaryngol. 2024 Feb;281(2):719-729. doi: 10.1007/s00405-023-08151-1. Epub 2023 Aug 7.
- Background: PubMed 37511722Kurz A, Herrmann D, Hagen R, Rak K. Using Anatomy-Based Fitting to Reduce Frequency-to-Place Mismatch in Experienced Bilateral Cochlear Implant Users: A Promising Concept. J Pers Med. 2023 Jul 8;13(7):1109. doi: 10.3390/jpm13071109.
- Background: PubMed 37823850Creff G, Lambert C, Coudert P, Pean V, Laurent S, Godey B. Comparison of Tonotopic and Default Frequency Fitting for Speech Understanding in Noise in New Cochlear Implantees: A Prospective, Randomized, Double-Blind, Cross-Over Study. Ear Hear. 2024 Jan-Feb 01;45(1):35-52. doi: 10.1097/AUD.0000000000001423. Epub 2023 Oct 12.
- Background: PubMed 36800505Dillon MT, Canfarotta MW, Buss E, Rooth MA, Richter ME, Overton AB, Roth NE, Dillon SM, Raymond JH, Young A, Pearson AC, Davis AG, Dedmon MM, Brown KD, O'Connell BP. Influence of Electric Frequency-to-Place Mismatches on the Early Speech Recognition Outcomes for Electric-Acoustic Stimulation Users. Am J Audiol. 2023 Mar;32(1):251-260. doi: 10.1044/2022_AJA-21-00254. Epub 2023 Feb 17.
- Background: PubMed 28277210Tan CT, Martin B, Svirsky MA. Pitch Matching between Electrical Stimulation of a Cochlear Implant and Acoustic Stimuli Presented to a Contralateral Ear with Residual Hearing. J Am Acad Audiol. 2017 Mar;28(3):187-199. doi: 10.3766/jaaa.15063.
- Background: PubMed 25719506Svirsky MA, Fitzgerald MB, Sagi E, Glassman EK. Bilateral cochlear implants with large asymmetries in electrode insertion depth: implications for the study of auditory plasticity. Acta Otolaryngol. 2015 Apr;135(4):354-63. doi: 10.3109/00016489.2014.1002052. Epub 2015 Feb 26.
- Background: PubMed 34131770Mertens G, Van de Heyning P, Vanderveken O, Topsakal V, Van Rompaey V. The smaller the frequency-to-place mismatch the better the hearing outcomes in cochlear implant recipients? Eur Arch Otorhinolaryngol. 2022 Apr;279(4):1875-1883. doi: 10.1007/s00405-021-06899-y. Epub 2021 Jun 15.
- Background: PubMed 32205726Canfarotta MW, Dillon MT, Buss E, Pillsbury HC, Brown KD, O'Connell BP. Frequency-to-Place Mismatch: Characterizing Variability and the Influence on Speech Perception Outcomes in Cochlear Implant Recipients. Ear Hear. 2020 Sep/Oct;41(5):1349-1361. doi: 10.1097/AUD.0000000000000864.
- Background: PubMed 35761459Goupell MJ, Noble JH, Phatak SA, Kolberg E, Cleary M, Stakhovskaya OA, Jensen KK, Hoa M, Kim HJ, Bernstein JGW. Computed-Tomography Estimates of Interaural Mismatch in Insertion Depth and Scalar Location in Bilateral Cochlear-Implant Users. Otol Neurotol. 2022 Jul 1;43(6):666-675. doi: 10.1097/MAO.0000000000003538.
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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.
Katelyn Glassman, AuD principal investigator
Med-El Corporation
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Programming of cochlear implant audio processor frequency settings in people with Hearing Loss, Unilateral and Cochlear Implants, run by Med-El Corporation at 6 sites in United States.
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 0 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percent correct on AzBio Sentences in Noise (time frame: 3 to 7 months). 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 NCT06734039, which also lists 17 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 27 Mar 2026.