Design Improvements With SONNET 3

Med-El Corporation20 enrolled

Overview

Measuring user-reported satisfaction with the latest behind-the-ear (BTE) audio processor model.

This prospective study will use a single-arm, repeated measures design with subjects serving as their own control. Participants will be experienced cochlear implant (CI) users wearing an approved BTE MED-EL audio processor. Participants will complete a take-home trial with the latest audio processor and then complete a custom questionnaire comparing design and usability to their existing audio processor.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hearing Loss, Sensorineural

Interventions

Audio processorDEVICE

MED-EL SONNET 3 (EAS) audio processor

Eligibility

Sex: ALLMin age: 7 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Implanted with a MED-EL cochlear implant in at least one ear * ≥ 12 months since activation of the MED-EL audio processor * Consistently using a SONNET (EAS) or SONNET 2 (EAS) Audio Processor * Ability to complete all study procedures * Participant and parental (if applicable) commitment to comply with all study procedures for the duration of the study Exclusion Criteria: * Evidence that hearing loss is retrocochlear in origin * Unable to provide reliable feedback during cochlear implant programming * Skin or scalp condition precluding use of the study device * Unrealistic participant or parent (if applicable) motivation or expectations * Participants without a stable fitting map at enrollment e.g., due to changes in hearing, global health status, etc.

Locations (1)

University of North Carolina

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Participants Reporting Improvement With SONNET 3 Design

The proportion of participants reporting improvement in design aspects of SONNET 3 (EAS) on a user survey

Time frame: Measured 1 month after baseline

Secondary Outcomes

Audiologist Satisfaction Ratings

Score on a 6-point Likert scale (1 = Strongly Disagree to 6 = Strongly Agree; higher scores indicate better outcomes). Values reported are the average scores on subsections of the audiologist survey.

Time frame: Measured after study completion, an average of 7.5 months

Data from ClinicalTrials.gov

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