Hearing Loss, SensorineuralNCT07500311
Comparison of Performance Using MED-EL Automatic Sound Management
A study testing Automatic Sound Management Fixed Directionality, Automatic Sound Management Adaptive and Omnidirectional Settings in people with Hearing Loss, Sensorineural and Cochlear Implantation, run by Med-El Corporation at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural, Cochlear Implantation
- What is being tested?
- Automatic Sound Management Fixed Directionality, Automatic Sound Management Adaptive and Omnidirectional Settings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2026to 17 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- Using electric-acoustic stimulation (EAS)
- Normal hearing in the unimplanted ear
- History of revision surgery in the study ear
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: 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.
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.
- Conditions
- Hearing Loss, Sensorineural, Cochlear Implantation
- Being tested
- Automatic Sound Management Fixed Directionality, Automatic Sound Management Adaptive, Omnidirectional Settings
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic Sound Management Fixed DirectionalityDevice
Also called ASM Fixed Directionality
The audio processor will be programmed with fixed directional microphones.
Automatic Sound Management AdaptiveDevice
Also called ASM Adaptive
The audio processor will be programmed with adaptive automatic sound management features.
Omnidirectional SettingsDevice
Also called Omnidirectional
The audio processor will be programmed with omnidirectional microphones and automatic sound management disabled.
| Study group | Role | What they receive |
|---|---|---|
| Sound Management Conditions | Experimental | Participants will complete speech-in-noise testing in all sound management and omnidirectional conditions. Receives: Device: Automatic Sound Management Fixed Directionality; Device: Automatic Sound Management Adaptive; Device: Omnidirectional Settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start25 Mar 2026
- Primary completion17 Jun 2026
- Study completion17 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Med-El Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brittany Wilson, AuD, Principal investigator, Med-El Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500311
- Sponsor's protocol ID
- US2502
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of MED-EL Automatic Sound Management Features for Enhancing Speech Understanding in Noise
- ClinicalTrials.gov ID
- NCT07500311
- Acronym / sponsor ID
- US2502
- Conditions
- Hearing Loss, Sensorineural, Cochlear Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Med-El CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 17 Jun 2026 (actual)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sound Management Conditions | Experimental | Device: Automatic Sound Management Fixed Directionality, Device: Automatic Sound Management Adaptive, Device: Omnidirectional SettingsParticipants will complete speech-in-noise testing in all sound management and omnidirectional conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥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
Key exclusion criteria (3 listed)
- Using electric-acoustic stimulation (EAS)
- Normal hearing in the unimplanted ear
- History of revision surgery in the study ear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic Sound Management Fixed DirectionalityAlso: ASM Fixed DirectionalityThe audio processor will be programmed with fixed directional microphones. | Device | Sound Management Conditions |
| Automatic Sound Management AdaptiveAlso: ASM AdaptiveThe audio processor will be programmed with adaptive automatic sound management features. | Device | Sound Management Conditions |
| Omnidirectional SettingsAlso: OmnidirectionalThe audio processor will be programmed with omnidirectional microphones and automatic sound management disabled. | Device | Sound Management Conditions |
Primary outcome
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.
1 secondary outcome
Individual and mean within-subject difference on HINT SNR-50 between ASM Adaptive settings.
Time frame: 0 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
Related trials for Hearing Loss, Sensorineural
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Active, not recruiting
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
Cochlear Implant Recipients, Hearing Loss, Cochlear
Active, not recruiting
Single-Sided Deafness and Asymmetric Hearing Loss
Hearing Loss, Unilateral, Hearing Loss, Sensorineural
Active, not recruiting
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Hearing Loss, Sensorineural, Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brittany Wilson, AuD principal investigator
Med-El Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic Sound Management Fixed Directionality, Automatic Sound Management Adaptive and Omnidirectional Settings in people with Hearing Loss, Sensorineural and Cochlear Implantation, run by Med-El Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual and mean within-subject difference on HINT SNR-50 between ASM Fixed Directionality and Omnidirectional conditions. (time frame: 0 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.