Impact of Anatomy-Based Cochlear Implant Programming on Early Performance

March 24, 2026 updated by: Med-El Corporation

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Durham, North Carolina, United States, 27516
        • Med-El Corporation
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  • At least 18 years of age
  • Is a cochlear implant candidate as deemed by the participating center
  • Implanted (or to be implanted) unilaterally with a MED-EL cochlear implant with moderately severe or better acoustic hearing in the contralateral ear.
  • For patients who are already implanted, device activation must have occurred within 2 weeks of enrollment
  • Patients with moderate contralateral hearing loss or greater must utilize a hearing aid in the contralateral ear.
  • Programmed with electric-only stimulation in the implanted ear
  • The ear to be implanted, acoustic hearing thresholds must be no better than 50 dBHL at 250 Hz and 65 dBHL at 500 Hz
  • Post-operative CT scan allows for completion of OTOPLAN analysis
  • ABF settings possible at defaults in clinical programming software
  • Minimum of 10 active electrodes at activation
  • Programmed using a Fine Structure coding strategy
  • English is the primary language
  • Willing and able to comply with all scheduled procedures as defined in the protocol

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Default Clinical Frequency Setting
The audio processor frequency setting will be programmed based on current frequency defaults in the clinical programming software
Device: Programming of cochlear implant audio processor frequency settings
Cochlear implant audio processor frequency settings will be adjusted within the clinical programming software
Other Names:
  • anatomy-based fitting
Active Comparator: Default Anatomy-Based Fitting
The audio processor frequency setting will be programmed based on current anatomy-based fitting frequency defaults in the clinical programming software
Device: Programming of cochlear implant audio processor frequency settings
Cochlear implant audio processor frequency settings will be adjusted within the clinical programming software
Other Names:
  • anatomy-based fitting
Experimental: Experimental Anatomy-Based Fitting 1
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.
Device: Programming of cochlear implant audio processor frequency settings
Cochlear implant audio processor frequency settings will be adjusted within the clinical programming software
Other Names:
  • anatomy-based fitting
Experimental: Experimental Anatomy-Based Fitting 2
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.
Device: Programming of cochlear implant audio processor frequency settings
Cochlear implant audio processor frequency settings will be adjusted within the clinical programming software
Other Names:
  • anatomy-based fitting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (%).
3 to 7 months
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.
Enrollment to 7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Audiogram
Time Frame: Enrollment and 12 months
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.
Enrollment and 12 months
Percent Correct on Az Bio Sentences in Noise
Time Frame: 12 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 (%).
12 months
Percent Correct on Consonant Nucleus Consonant (CNC) Words
Time Frame: 3 to 12 months
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.
3 to 12 months
Subjective feedback questionnaire
Time Frame: Enrollment to 12 months
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.
Enrollment to 12 months
Psychoacoustic Testing of Sound Quality and Preference
Time Frame: 7 months
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.
7 months
Cochlear Implant Quality of Life- 35 Profile (CIQoL35)
Time Frame: 12 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.
12 months
Decisional Regret Scale
Time Frame: 3 to 12 months
A validated questionnaire using a 5-point Likert scale to assess decisional regret after cochlear implantation.
3 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Med-El Corporation

Investigators

  • Principal Investigator: Katelyn Glassman, AuD, Med-El Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 10, 2024

First Posted (Actual)

December 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US2401 MED-EL ABF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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