Comparison of Performance Using MED-EL Automatic Sound Management

March 24, 2026 updated by: Med-El Corporation

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina, Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sound Management Conditions
Participants will complete speech-in-noise testing in all sound management and omnidirectional conditions.
Device: Automatic Sound Management Fixed Directionality
The audio processor will be programmed with fixed directional microphones.
Other Names:
  • ASM Fixed Directionality
Device: Automatic Sound Management Adaptive
The audio processor will be programmed with adaptive automatic sound management features.
Other Names:
  • ASM Adaptive
Device: Omnidirectional Settings
The audio processor will be programmed with omnidirectional microphones and automatic sound management disabled.
Other Names:
  • Omnidirectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual and mean within-subject difference on HINT SNR-50 between ASM Fixed Directionality and Omnidirectional conditions.
Time Frame: 0 days
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.
0 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual and mean within-subject difference on HINT SNR-50 between ASM Adaptive settings.
Time Frame: 0 days
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.
0 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Med-El Corporation

Investigators

  • Principal Investigator: Brittany Wilson, AuD, Med-El Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US2502

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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