Speech Processor Programming for Single-Sided Deafness with Cochlear Implant

Not currently recruiting at 2 trial locations

Overseen By Jill B Firszt, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Not meeting inclusion criteria

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance speech understanding and sound localization for individuals with single-sided deafness (hearing loss in one ear). It targets those with a cochlear implant, adjusting the implant's speech processor to balance sound between the ears. Participants may be either experienced cochlear implant users or newly implanted. Eligible individuals are adults who became deaf in one ear after learning to speak and have normal hearing in the other ear. As an unphased trial, this study provides a unique opportunity to advance cochlear implant technology and improve hearing outcomes.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these speech processor program modifications are safe for cochlear implant recipients with single-sided deafness?

Research shows that cochlear implants (CIs) for single-sided deafness (SSD) are generally safe. Users often experience improved hearing and speech understanding. Studies have found that adjusting the cochlear implant's settings can enhance hearing in noisy environments and help users locate sound sources, with these adjustments usually well-tolerated.

The FDA has approved similar cochlear implant systems for other uses, indicating their safety. Although the adjustments to the implant settings in this trial are new, they rely on technology already known to be safe and effective. Similar studies have reported no major safety issues, but as with any trial, some risk exists. Participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative programming techniques for cochlear implants in people with single-sided deafness. Unlike traditional cochlear implant programming, which might not address the subtle differences in frequency and loudness between ears, this approach fine-tunes the speech processor to minimize mismatches. By reducing these mismatches, the programming aims to enhance sound perception and overall hearing experience, potentially offering a more balanced auditory experience than current standard methods. This could lead to improved outcomes and satisfaction for cochlear implant users with single-sided deafness.

What evidence suggests that these speech processor program modifications are effective for single-sided deafness?

This trial will explore different programming adjustments to cochlear implants (CIs) for individuals with single-sided deafness. Research has shown that adjusting CIs can improve speech recognition and sound localization. In this trial, some participants will receive programming changes to decrease the interaural frequency mismatch, while others will have adjustments to decrease the interaural loudness mismatch. These changes can make it easier to hear speech in noisy environments by balancing sound between both ears. Studies have found that such adjustments can enhance hearing in the implanted ear and may also reduce tinnitus (ringing in the ears). Overall, individuals with hearing in one ear who receive these adjustments often experience a better quality of life. ^{3 6 7 8 9}

Who Is on the Research Team?

Jill B Firszt, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with single-sided deafness (SSD) who have normal hearing in one ear and are either experienced users of a Nucleus cochlear implant or will be newly implanted. They must have had postlingual onset of SSD, meaning they became deaf after having learned to speak.

Inclusion Criteria

Implanted with or chosen to be implanted with a Nucleus cochlear implant

I am an adult with hearing loss in one ear.

Postlingual onset of SSD

Exclusion Criteria

Not meeting the inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

CI speech processor programming to reduce interaural loudness and pitch mismatch

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Treatment-modifications to CI speech processor program

Trial Overview The study tests modifications to the speech processor program of cochlear implants in individuals with SSD. The goal is to improve binaural cues which help with understanding speech in noisy environments and sound localization by reducing loudness and pitch differences perceived between ears.

How Is the Trial Designed?

Group I: Period 3: study 3 Experimental Treatment 1 Intervention

CI speech processor programming in experienced cochlear implant (CI) recipients with single sided deafness. Program changes were made to decrease the interaural loudness mismatch between the CI ear and the contralateral ear.

Group II: Period 2: Study 2 Experimental Treatment 1 Intervention

CI speech processor programming in newly implanted cochlear implant (CI) recipients with single sided deafness. Program changes were made to decrease the interaural frequency mismatch between the CI ear and the contralateral ear.

Group III: Period 1: Study 1 Experimental Treatment 1 Intervention

CI speech processor programming in experienced cochlear implant (CI) recipients with single sided deafness. Program changes were made to decrease the interaural frequency mismatch between the CI ear and the contralateral ear.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Cochlear

Industry Sponsor

Trials

96

Recruited

6,300+

Headquarters

Sydney, Australia

Dig Howitt

Cochlear

Chief Executive Officer since 2018

BE (Hons), MBA

Michael del Prado

Cochlear

Chief Medical Officer since 2022

MD, MSc, FRACP, FAAHMS, FAICD

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12244958/

Long-Term Results in Cochlear Implantation in Single-Sided ... The improvements observed are in speech recognition in the implanted ear and suppression of tinnitus if it is associated with hearing loss.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12317272/

Improving Outcomes of Single-Sided Deaf Cochlear ... The study aimed to improve outcomes in Nucleus cochlear implant (CI) recipients with single-sided deafness (SSD) by reducing interaural frequency and ...

3. blog.medel.pro blog.medel.pro/audiology/cochlear-implantation-outcomes-in-adults-with-unilateral-deafness-speech-perception-tinnitus-sound-localization-and-quality-of-life/

Cochlear Implantation Outcomes in Adults With Unilateral ... Adults with unilateral deafness often see improvements in speech recognition, sound localization, tinnitus, and quality of life after CI.

4. pronews.cochlear.com pronews.cochlear.com/wp-content/uploads/2025/02/FUN4699-ISS4-NOV24-SSD-White-Paper-1.pdf

2024 Clinical Recommendations for the Treatment of ... Single-sided deafness (SSD) impacts over 345,000 adults in the United States, with an estimated 5.2% experiencing some degree of unilateral hearing loss.

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.760831/full

Cochlear Implants in Single-Sided Deafness. Comparison ... Cochlear implantation in post-lingually deaf adults and children with SSD can achieve a speech perception outcome comparable with CI in conventional candidates.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40739862/

Improving Outcomes of Single-Sided Deaf Cochlear ... The study aimed to improve outcomes in Nucleus cochlear implant (CI) recipients with single-sided deafness (SSD) by reducing interaural ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02203305

Cochlear Implantation in Cases of Single-Sided Deafness The primary goal of this project is to determine whether subjects with Single-Sided Deafness (SSD) experience an improvement in speech perception, localization, ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P000025S104B.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) In the MED-EL Cochlear Implant System, the audio processor analyzes the sound signal from the microphone according to the speech coding strategy ...

9. withpower.com withpower.com/trial/phase-to-improve-speech-understanding-in-noise-and-localization-in-ssd-ci-recipients-7-2022-cc576

Speech Processor Programming for Single-Sided ... This trial is for adults over 18 with single-sided deafness (SSD) who have normal hearing in one ear and are either experienced users of a Nucleus cochlear ...