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Enrolling by Invitation

NCT Number: NCT06734039

Impact of Anatomy-Based Cochlear Implant Programming on Early Performance

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.

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Key information

Conditions

Hearing Loss, Unilateral Asymmetric Hearing Loss Cochlear Implants Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Single-Sided Deafness (SSD)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa, Iowa City, Iowa, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Programming of cochlear implant audio processor frequency settings

Device

Cochlear implant audio processor frequency settings will be adjusted within the clinical programming software

Other names: anatomy-based fitting

Primary outcomes

  1. 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 (%).

  2. 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.

Secondary outcomes

  1. 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.

  2. 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 (%).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Med-El Corporation

Industry

Registry information

Official study title

Impact of Anatomy-Based Frequency (ABF) Allocations on Early Performance Outcomes in MED-EL Cochlear Implant Recipients

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 13, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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