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Comparison of Performance Using MED-EL Automatic Sound Management

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07500311
Enrollment
20
Registered
2026-03-30
Start date
2026-04-01
Completion date
2028-01-01
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cochlear Implantation, Hearing Loss, Sensorineural

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.

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

DEVICEAutomatic Sound Management Fixed Directionality

The audio processor will be programmed with fixed directional microphones.

DEVICEAutomatic Sound Management Adaptive

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

DEVICEOmnidirectional Settings

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

Sponsors

Med-El Corporation
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Individual and mean within-subject difference on HINT SNR-50 between ASM Fixed Directionality and Omnidirectional conditions.0 daysSpeech 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

MeasureTime frameDescription
Individual and mean within-subject difference on HINT SNR-50 between ASM Adaptive settings.0 daysThe 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBrittany Wilson, AuD

Med-El Corporation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026