Comparison of Performance Using MED-EL Automatic Sound Management

NCT07500311 | Enrolling By Invitation FDA Device

• 1 other identifier: US2502
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hearing Loss, Sensorineural; Cochlear Implantation

Outcome Measures

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.

  0 days

Secondary Outcomes (1)

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

  0 days

Study Arms (1)

Sound Management Conditions

EXPERIMENTAL

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

Automatic Sound Management Fixed Directionality DEVICE

The audio processor will be programmed with fixed directional microphones.

Also known as: ASM Fixed Directionality

Sound Management Conditions

Automatic Sound Management Adaptive DEVICE

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

Also known as: ASM Adaptive

Sound Management Conditions

Omnidirectional Settings DEVICE

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

Also known as: Omnidirectional

Sound Management Conditions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

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

Sponsors & Collaborators

• Med-El Corporation: lead

Study Sites (1)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

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

Study Officials

• Brittany Wilson, AuD

  Med-El Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will complete speech perception testing with various combinations of automatic sound management features. The order of program conditions will be randomized across subjects.

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)