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Enrolling by invitation NCT07500311

Comparison of Performance Using MED-EL Automatic Sound Management

No phase Interventional Hearing Loss, Sensorineural Cochlear Implantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Automatic Sound Management Fixed Directionality, Automatic Sound Management Adaptive, Omnidirectional Settings.
Who it may be relevant to
Registry conditions: Hearing Loss, Sensorineural, Cochlear Implantation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Comparison of MED-EL Automatic Sound Management Features for Enhancing Speech Understanding in Noise

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.

Detailed description

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.

Interventions

  • Device Automatic Sound Management Fixed Directionality
    The audio processor will be programmed with fixed directional microphones.
  • Device Automatic Sound Management Adaptive
    The audio processor will be programmed with adaptive automatic sound management features.
  • Device Omnidirectional Settings
    The audio processor will be programmed with omnidirectional microphones and automatic sound management disabled.

Primary outcome measures

  • Individual and mean within-subject difference on HINT SNR-50 between ASM Fixed Directionality and Omnidirectional conditions. [Time frame: 0 days]
Secondary outcome measures (1)
  • Individual and mean within-subject difference on HINT SNR-50 between ASM Adaptive settings. [Time frame: 0 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of North Carolina, Chapel Hill — Chapel Hill

Identifiers

NCT: NCT07500311 · US2502

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗