Impact of Anatomy-Based Cochlear Implant Programming on Early Performance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2028-10-31

Brief Summary

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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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Detailed Description

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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

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Hearing Loss, Unilateral Cochlear Implants Hearing Loss, Sensorineural Single-Sided Deafness (SSD) Asymmetric Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants will be blinded to each of the frequency settings they are utilizing.

Study Groups

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Default Clinical Frequency Setting

The audio processor frequency setting will be programmed based on current frequency defaults in the clinical programming software

Group Type ACTIVE_COMPARATOR