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Enrolling by invitationNCT07500311Updated Mar 30, 2026

Comparison of Performance Using MED-EL Automatic Sound Management

An interventional study of Automatic Sound Management Fixed Directionality and Automatic Sound Management Adaptive in Hearing Loss, Sensorineural and Cochlear Implantation, sponsored by Med-El Corporation. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Med-El Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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.

02

Conditions studied

  • Hearing Loss, Sensorineural
  • Cochlear Implantation
03

In context

Hearing Loss, Sensorineural

371 studies on the registry are indexed under Hearing Loss, Sensorineural; 112 are open to participants now.

This study's planned enrollment of 20 is below the median of 32 across 264 interventional studies indexed under Hearing Loss, Sensorineural.

Browse Hearing Loss, Sensorineural studies →

Lead sponsor

Med-El Corporation is the lead sponsor of 16 studies on the registry; 3 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Using electric-acoustic stimulation (EAS)
  • Normal hearing in the unimplanted ear
  • History of revision surgery in the study ear
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Sound Management Conditions

    Participants will complete speech-in-noise testing in all sound management and omnidirectional conditions.

    Device: Automatic Sound Management Fixed Directionality · Device: Automatic Sound Management Adaptive · Device: Omnidirectional Settings

Interventions

  • DeviceAutomatic Sound Management Fixed Directionality

    The audio processor will be programmed with fixed directional microphones.

    Also known as: ASM Fixed Directionality

  • DeviceAutomatic Sound Management Adaptive

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

    Also known as: ASM Adaptive

  • DeviceOmnidirectional Settings

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

    Also known as: Omnidirectional

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

1 site
  • University of North Carolina, Chapel Hill
    Chapel Hill, North Carolina 27599, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07500311
Lead sponsor
Med-El Corporation
Responsible party
Sponsor
First posted
Mar 30, 2026
Start date
Apr 2026 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Mar 30, 2026

Study contacts

Brittany Wilson, AuD
principal investigator · Med-El Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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