Comparison of Performance Using MED-EL Automatic Sound Management

N/AEnrolling By InvitationNCT07500311

Med-El Corporation20 enrolled

Overview

This study will evaluate the speech perception ability of adult cochlear implant users in background noise using various MED-EL Automatic Sound Management (ASM) features.

This study will examine how different sound processing approaches support cochlear implant users' ability to understand speech in noisy environments. Automated noise reduction and microphone directionality systems are known to improve listening comfort and speech clarity in challenging settings. Ongoing refinements in these areas may offer additional benefits and allow for more individualized listening options. In this study, adult cochlear implant users will take part in speech-in-noise evaluations while using various sound processing configurations.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hearing Loss, Sensorineural Cochlear Implantation

Interventions

Automatic Sound Management Fixed DirectionalityDEVICE

The audio processor will be programmed with fixed directional microphones.

Automatic Sound Management AdaptiveDEVICE

The audio processor will be programmed with adaptive automatic sound management features.

Omnidirectional SettingsDEVICE

The audio processor will be programmed with omnidirectional microphones and automatic sound management disabled.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥18 years of age at time of enrollment * Implanted with a MED-EL cochlear implant * At least 6 months since activation their cochlear implant * Aided speech perception score of ≥40% on CNC words in quiet in study ear * English is the primary language * Established daily use of the audio processor * Currently using an audio processor compatible with Automatic Sound Management 2.0 or later * Willing and able to comply with study procedures Exclusion Criteria: * Using electric-acoustic stimulation (EAS) * Normal hearing in the unimplanted ear * History of revision surgery in the study ear

Locations (1)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Individual and mean within-subject difference on HINT SNR-50 between ASM Fixed Directionality and Omnidirectional conditions.

Speech perception ability will be measured using the Hearing in noise Test (HINT) sentences in an adaptive procedure. HINT sentences will be presented from the front with continuous, steady-state noise presented at 65 dBA from behind. The presentation level of the speech signal will be adjusted based on participant response. The difference in dB SNR between the ASM Fixed Directionality and Omnidirectional conditions will be summarized. Results for each condition will be reported in dB SNR defined as the SNR level at which 50% score is achieved.

Time frame: 0 days

Secondary Outcomes

Individual and mean within-subject difference on HINT SNR-50 between ASM Adaptive settings.

The HINT SNR-50 task will be completed using different adaptive automatic sound management features. The difference in dB SNR between the conditions will be summarized. Results for each condition will be reported in dB SNR defined as the SNR level at which 50% score is achieved.

Time frame: 0 days

Data from ClinicalTrials.gov

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