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Enrolling by Invitation

NCT Number: NCT07500311

Comparison of Performance Using MED-EL Automatic Sound Management

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.

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Key information

Conditions

Hearing Loss, Sensorineural Cochlear Implantation Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automatic Sound Management Fixed Directionality

Device

The audio processor will be programmed with fixed directional microphones.

Other names: ASM Fixed Directionality

Automatic Sound Management Adaptive

Device

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

Other names: ASM Adaptive

Omnidirectional Settings

Device

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

Other names: Omnidirectional

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Med-El Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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