Automatic Sound Management for Cochlear Implants

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Med-El Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help adults with cochlear implants understand speech better in noisy environments. Researchers are testing various Automatic Sound Management settings to determine which ones enhance speech perception the most. Individuals who have used a MED-EL cochlear implant for at least six months and regularly use a compatible audio processor may qualify for this trial. As an unphased trial, it offers a unique opportunity to contribute to advancements in cochlear implant technology and potentially improve participants' hearing experiences.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these sound management techniques are safe for cochlear implant users?

Research has shown that the Automatic Sound Management (ASM) features in cochlear implants are safe and generally well-received by users. Studies have found that the SONNET 2 audio processor, which includes these features, helps users hear better and understand speech in noisy environments. No major problems have been reported in connection with these features.

For the Automatic Sound Management Adaptive and Fixed Directionality settings, studies confirm they enhance speech understanding and sound quality without major safety issues. These features are designed to improve hearing in noisy situations without causing harm.

Regarding Omnidirectional Settings, research suggests these settings offer good speech understanding and are as safe as other settings. They are commonly used in cochlear implants and have been proven safe over time.

Overall, these sound management features are part of well-established cochlear implant systems approved for use, demonstrating their safety and reliability.12345

Why are researchers excited about this trial?

Researchers are excited about the trial for Automatic Sound Management in cochlear implants because it explores innovative ways to improve how users hear in noisy environments. Unlike traditional settings that rely on fixed directionality or omnidirectional sound processing, this approach features an adaptive system that automatically adjusts to the listening environment. This could potentially offer users a more natural and seamless hearing experience, enhancing speech clarity without manual adjustments. By examining how these different sound management techniques compare, the study aims to identify the most effective method for improving auditory outcomes in real-world situations.

What evidence suggests that this trial's treatments could be effective for improving speech perception in background noise for cochlear implant users?

Research has shown that Automatic Sound Management (ASM) systems enhance speech understanding in noisy environments. Studies have found that ASM features help cochlear implant users recognize speech more easily and reduce listening effort. In this trial, participants will experience various ASM settings. The Adaptive ASM, one setting under study, proves especially effective by automatically adjusting to different sound environments, thus improving speech understanding in noisy settings. Meanwhile, the Fixed Directionality ASM, another setting being tested, enhances speech clarity by focusing on sounds from one direction. Both systems aim to improve hearing in challenging places, such as busy restaurants or crowded streets.23678

Who Is on the Research Team?

BW

Brittany Wilson, AuD

Principal Investigator

Med-El Corporation

Are You a Good Fit for This Trial?

This trial is for adults (18+) who have a MED-EL cochlear implant that has been active for at least 6 months, use their audio processor daily, speak English as their main language, and can understand at least some speech with the device.

Inclusion Criteria

* 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
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete speech-in-noise testing using various MED-EL Automatic Sound Management features

0 days

Follow-up

Participants are monitored for any changes in speech perception ability post-testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Automatic Sound Management Adaptive
  • Automatic Sound Management Fixed Directionality
  • Omnidirectional Settings

Trial Overview

The study compares different sound management settings—adaptive directionality, fixed directionality, and omnidirectional—on MED-EL cochlear implants to see which helps users best understand speech in noisy environments.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Sound Management ConditionsExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Med-El Corporation

Lead Sponsor

Trials
27
Recruited
2,100+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36108069/

Improved performance with automatic sound management ...

The primary aim of this study was to evaluate if using these features improves speech perception in noise, subjective listening effort, and sound quality.

Improved performance with automatic sound management 3 ...

The primary aim of this study was to evaluate if using these features improves speech perception in noise, subjective listening effort, and sound quality.

Automatic Sound Management 3.0 with the SONNET 2 and ...

(2004) showed that listening effort and speech recognition scores were significantly improved by pre-processing signals with hearing aid noise reduction.

Clinical improvement of speech perception in noise with ...

This study evaluated the effects of a new front-end signal processing framework, Automatic Sound Management 3.0 (ASM 3.0), on the perception of speech in noise ...

Automatic Sound Management 3.0 in a... | Clinical Trial

Cochlear implants are routine treatment for people with severe hearing loss. This study tests the RONDO 3, MED-EL's newest single-unit audio ...

Improved performance with automatic sound management 3 ...

The SONNET 2 audio processor features ambient noise reduction (ANR), transient-noise reduction (TNR), and adaptive intelligence (AI).

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

The “MED-EL EAS System” is an electric-acoustic stimulation (EAS) cochlear implant system. The MED-EL EAS System provides an electric ...

Automatic Sound Management for Cochlear Implants

This study will evaluate the speech perception ability of adult cochlear implant users in background noise using various MED-EL Automatic ...