22 Participants Needed

Alternative Frequency Mapping for Cochlear Implant Users

NH
MA
Overseen ByMario A. Svirsky, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
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 explores how different frequency settings in cochlear implants affect individuals with hearing in only one ear. Participants will use four different sound settings in their new implant to determine which provides the best sound quality and speech understanding. The study aims to discover if changing these settings, known as Alternative Frequency Mapping, can improve hearing experiences and increase device usage. It suits those planning to receive a cochlear implant in one ear while maintaining normal hearing in the other. As an unphased trial, this study allows participants to contribute to innovative research that could enhance cochlear implant technology for future users.

Do I have to stop taking 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 this alternative frequency mapping is safe for cochlear implant users?

Studies have shown that people with cochlear implants generally handle the expected risks well. Research indicates that adjusting sound frequencies in cochlear implants can be fine-tuned to better match natural hearing. This process, called frequency mapping, is being studied to improve sound quality and speech understanding.

There is no direct data on the safety of the specific frequency settings tested in this trial. However, cochlear implant technology has been widely used and is FDA-approved for other uses, suggesting it is generally safe. Most recipients do not experience serious side effects, though some may feel mild discomfort as they adjust to the new sound settings.

Overall, the technology and its adjustments are considered well-tolerated. Participants in this study will try different sound settings to find what works best for them, ensuring safety and comfort.12345

Why are researchers excited about this trial?

Most treatments for single-sided deafness with cochlear implants use standard frequency mapping, typically covering the range from 188 to 7938 Hz. However, the alternative frequency mapping being studied introduces maps with higher low-frequency edges starting at 313, 438, and 563 Hz. Researchers are excited about this approach because it allows users to alternate between different frequency maps daily, potentially improving sound quality and user satisfaction. This method offers a personalized experience, enabling users to choose the most comfortable map after trialing different options, which could lead to better auditory outcomes compared to the conventional approach.

What evidence suggests that this alternative frequency mapping is effective for cochlear implant users?

This trial will explore the effects of Alternative Frequency Mapping for cochlear implant users. Research suggests that altering how cochlear implants process sound might enhance hearing. Studies have shown that reducing the mismatch between the implant's sound settings and the ear's natural hearing can increase benefits for users. For instance, adjusting the implant to align with the ear's natural hearing areas may improve speech understanding. Many recipients can adapt to new sound settings, even after prolonged periods without hearing. Overall, these changes could lead to better sound quality and speech understanding for cochlear implant users.45678

Who Is on the Research Team?

MA

Mario A. Svirsky, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals who have recently received a cochlear implant to address single-sided deafness. Participants should be new users of the device, ready to test different frequency mapping strategies over the first month post-activation.

Inclusion Criteria

English speaking
My hearing in the opposite ear is normal or nearly normal.
I do not have any known ear abnormalities.
See 2 more

Exclusion Criteria

I am under 18 years old.
Non-English speaking
My implanted ear has a documented structural abnormality.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use four frequency maps for the first month after CI activation, alternating daily, to study adaptation in SSD-CI users.

4 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for speech perception and sound quality using various frequency maps.

12 months
Monthly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Alternative Frequency Mapping
Trial Overview The study tests how newly implanted cochlear implant users adapt using four different frequency maps. One map follows standard care while the others vary in low-frequency edges. Subjects will switch maps daily initially, then weekly choose which they prefer.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) UsersExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

Citations

Learning to hear again with alternating cochlear frequency ...This study shows that recipients, after a long period of sound deprivation, preserve a level of auditory plasticity, enabling them to swiftly and concurrently ...
Effectiveness of Place-Based Mapping in Electric-Acoustic ...Aligning the electric frequency filters via a place-based mapping procedure using postoperative imaging may improve speech recognition with EAS.
Can Reducing Tonotopic Mismatch Improve Hearing ...There is growing evidence that cochlear implant recipients may benefit more from their devices if tonotopic mismatch is reduced.
Exploring the intersection of cochlear implants and artificial ...Machine learning techniques have been applied to predict cochlear implant outcomes by leveraging diverse data sources: clinical comorbidities such as ...
Imaging-based frequency mapping for cochlear implantsWe introduce an imaging-based fitting intervention, which aimed to reduce frequency-to-place mismatch by aligning frequency mapping with the tonotopic position ...
Pediatric cochlear implantation: The impact of frequency-to ...Frequency-to-place mismatch in cochlear implants (CIs) may influence auditory and speech outcomes, yet its impact on pediatric patients ...
2024 Clinical Recommendations for the Treatment of ...Contraindications for bone conduction implantation include the following: 1) insufficient bone quality or quantity to support implantation of both the BI300 ...
Summary of Safety and Effectiveness Data (SSED)The safety data from the feasibility study and a literature search suggest that cochlear implant recipients tolerate the anticipated risks ...
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