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Clinical Trials in the USA / NCT06734039
Enrolling by invitation Not applicable

Impact of Anatomy-Based Cochlear Implant Programming on Early Performance

NCT06734039 · tracked via the Priya Life Science USA tracker
Sponsor
Med-El Corporation
Phase
Not applicable
Started
2025-11-10
Last updated
2026-03-27

Condition(s) studied

Hearing Loss, UnilateralCochlear ImplantsHearing Loss, SensorineuralSingle-Sided Deafness (SSD)Asymmetric Hearing Loss

Investigational drug(s) / intervention(s)

Programming of cochlear implant audio processor frequency settings

Programming of cochlear implant audio processor frequency settings: Cochlear implant audio processor frequency settings will be adjusted within the clinical programming software

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
* 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required to use a hearing aid per inclusion criteria who stop use of a hearing aid in the contralateral ear will be withdrawn at the time of discontinued hearing aid use * Subjects who receive a cochlear implant in the contralateral ear prior to the 12-month interval

Primary outcome measure(s)

  • Percent correct on AzBio Sentences in Noise — 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) — 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.

Trial sites (6)

FacilityCityRegionStatus
University of Iowa Iowa City Iowa
University of Kansas Medical Center Kansas City Kansas
University of North Carolina Chapel Hill North Carolina
MED-EL Corporation Durham North Carolina
Oregon Health and Science University Portland Oregon
Thomas Jefferson University Philadelphia Pennsylvania

More Med-El Corporation trials in the USA

Single-Sided Deafness and Asymmetric Hearing Loss Active, not recruiting
Expanded Indications in the Pediatric BONEBRIDGE Population Active, not recruiting

Other trials for the same condition

Single-Sided Deafness and Asymmetric Hearing Loss Active, not recruiting
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness Active, not recruiting
Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population Active, not recruiting
Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery Recruiting
Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06734039 on ClinicalTrials.gov ↗ ← All trials in the USA