Bimodal Streaming for Hearing Loss

Overseen By Ivy Chen

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Med-El Corporation

Disqualifiers: Unable to provide feedback, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new bimodal streaming option for individuals using both a MED-EL cochlear implant and a Starkey hearing aid. Researchers focus on assessing sound quality and user satisfaction with Bluetooth streaming in this setup. Individuals with a MED-EL cochlear implant in one ear and a compatible Starkey hearing aid may be suitable candidates for this study if they wish to try Bluetooth streaming. Participants must have a smartphone capable of running the AudioKey app and be able to complete an online survey. As an unphased trial, this study provides a unique opportunity to contribute to innovative research and potentially enhance personal 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 this bimodal streaming configuration is safe for individuals with hearing loss?

Research has shown that cochlear implants, including those used in the bimodal streaming setup, are generally safe and effective. Individuals using bimodal hearing—where a cochlear implant and a hearing aid work together—often experience better speech understanding and an improved quality of life.

Although specific studies on this new bimodal streaming option are not yet available, the combination of cochlear implants and hearing aids has been well-received. No specific reports of problems with this new setup have emerged. However, as with any medical device, consulting a doctor for any concerns is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about bimodal streaming for hearing loss because it offers a new way to improve hearing by combining two different types of hearing technologies: a cochlear implant and a hearing aid. Unlike traditional hearing aids or cochlear implants used alone, this dual approach aims to enhance sound quality and speech understanding by utilizing the strengths of both devices. This method holds promise for providing a more natural hearing experience, particularly in challenging listening environments, which could be a game-changer for those with hearing loss.

What evidence suggests that this bimodal streaming configuration is effective for hearing loss?

Studies have shown that using both a cochlear implant and a hearing aid, known as bimodal streaming, can improve hearing. Research indicates that this setup helps people understand speech better in noisy environments, with hearing clarity improvements ranging from 1.4 dB to 3.5 dB. Bimodal hearing also aids in sound localization, allowing individuals to identify sound sources more accurately. Early patient feedback on this technology has been positive regarding sound quality. Overall, evidence suggests that bimodal streaming effectively enhances hearing for those with uneven hearing loss. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with unilateral or bilateral hearing loss who use a MED-EL cochlear implant in one ear and a Starkey hearing aid. Participants must be smartphone users, familiar with Bluetooth streaming, able to complete surveys online, and not have any issues that would prevent them from providing reliable feedback or operating a smartphone.

Inclusion Criteria

Using a smartphone that can support the AudioKey application

Implanted with a MED-EL cochlear implant in one ear

Using an AudioKey compatible Starkey hearing aid

Exclusion Criteria

Unable to provide reliable feedback

Unable to operate a smartphone with or without assistance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants evaluate the new Bluetooth streaming option with their MED-EL cochlear implant and Starkey hearing aid

1 week

1 visit (in-person)

Follow-up

Participants are monitored for user satisfaction and sound quality after using the new streaming option

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bimodal Streaming Configuration

Trial Overview The study is testing the sound quality and satisfaction of using Bluetooth for bimodal streaming between MED-EL cochlear implants and Starkey hearing aids. It involves completing surveys about participants' experiences with this new technology.

How Is the Trial Designed?

Group I: Bimodal streaming Experimental Treatment 1 Intervention

Bimodal streaming

Who Is Running the Clinical Trial?

Med-El Corporation

Lead Sponsor

Trials

27

Recruited

2,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11309062/

The Benefit of Bimodal Hearing and Beamforming for ... A bimodal configuration for patients with residual hearing in the non-implanted ear can be beneficial, even when one ear outperforms the other.

2. tandfonline.com tandfonline.com/doi/full/10.1080/14992027.2024.2341954

Full article: Integrated bimodal fitting and binaural ... Bimodal outcomes were significantly better than for CI alone. Speech perception in noise improvements ranged from 1.4 dB to 3.5 dB depending on the location of ...

3. blog.medel.pro blog.medel.pro/en-us/cochlear-implants/expanding-access-to-seamless-bimodal-streaming-with-med-el-and-starkey/

Expanding Access to Seamless Bimodal Streaming with ... In a study conducted at Idaho Ear Clinic in Meridian, ID, the world's first patients to use DualSync provided early feedback on sound quality ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07028619

Benefits of Bimodal Streaming With MED-EL Cochlear ... This study will evaluate sound quality and user satisfaction with Bluetooth streaming using a new bimodal streaming option for individuals who use a MED-EL ...

5. assets.cochlear.com assets.cochlear.com/api/public/content/FUN4734-SHA-Bimodal-Hearing-Evidence-Summary.pdf

Bimodal Hearing Evidence Summary Conclusion: For this group of postlingual adults with asymmetric hearing loss, bimodal hearing was effective at reducing errors in sound localization.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6203455/

Bimodal Hearing in Individuals with Severe-to-Profound ... In cases of bilateral hearing loss when only a monaural HA is used, speech perception ability decreases over time in the unaided ear.

7. medel.com medel.com/en-us/important-safety-information

Important Safety Information Find important safety information about MED-EL's implant systems. Just select your country and your implant system using the menu below.