Speech Processor Programming for Single-Sided Deafness with Cochlear Implant
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.12345Why 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.36789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
CI speech processor programming to reduce interaural loudness and pitch mismatch
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
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Treatment groups
Experimental Treatment
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Cochlear
Industry Sponsor
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
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.
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 ...
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.pdf2024 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.
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.
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 ...
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, ...
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-cc576Speech 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 ...
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