Population Mean Mapping for Hearing Loss

Overseen By Arenberg

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts Eye and Ear Infirmary

Disqualifiers: Other devices, Pre-lingually deafened, Multiple disabilities, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

48 Participants Needed

Trial Summary

What is the purpose of this trial?

The study is about the importance of each follow-up visit after activating a new cochlear implant in addition to evaluating the effectiveness and efficiency of a new programming strategy from Cochlear Americas. Investigators are looking for patients who have recently selected Cochlear Americas as their cochlear implant manufacturer of choice for their upcoming surgery. The aim of this study is to determine if 1) patient outcomes remain stable when reducing follow-up appointments and 2) Cochlear's population mean mapping can produce similar outcomes with patients while additionally reducing appointment times. The hypothesis is that using population mean mapping and reducing the number of follow-up visits after activation will yield similar performance outcomes to a standard of care while decreasing the length of appointment times and number of appointments needed for each patient.

Will I have to stop taking my current medications?

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

How does the treatment Population Mean Mapping for Hearing Loss differ from other treatments for hearing loss?

Population Mean Mapping for Hearing Loss is unique because it focuses on understanding and mapping the average hearing loss across different populations, which can help tailor more precise and effective treatments. Unlike traditional methods that categorize hearing loss into a few types, this approach uses data-driven models to capture a wider range of hearing loss profiles, potentially leading to more personalized and accurate interventions. ^{1 2 3 4 5}

Research Team

Julie Arenberg

Principal Investigator

Massachusetts Eye and Ear

Eligibility Criteria

This trial is for patients who are about to receive a cochlear implant from Cochlear Americas. It's designed to see if fewer follow-up visits and a new programming strategy work just as well as the current standard care.

Inclusion Criteria

New cochlear implant recipients with Cochlear Americas devices identified prior to activation

I became deaf after learning to speak and am over 18.

I can follow instructions and respond to tests like repeating words or answering questions.

Exclusion Criteria

Pre-lingually deafened individuals

Individuals with multiple disabilities

Unable to perform follow-up testing tasks (repeating words/sentences, indicating they heard a sound stimulus, completing questionnaires)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a cochlear implant and undergo initial programming using either traditional or population mean mapping strategies

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for speech perception, quality of life, and programming stability over a 1-year period

1 year

Multiple visits (in-person)

Treatment Details

Interventions

• Changes in traditional follow-up
• Population mean mapping

Trial Overview The study tests whether reducing scheduled follow-ups and using Cochlear America's population mean mapping maintains patient outcomes. The goal is to compare this approach with traditional post-implantation care.

Participant Groups

Group I: Traditional mapping*, without 1 week follow-up Experimental Treatment 1 Intervention

Reduction in the number of follow-up visits.

Group II: Population mean mapping, without 1 week follow-up Experimental Treatment 2 Interventions

Reduction in the number of follow-up visits and new programming strategy.

Group III: Population mean mapping, traditional follow-up Experimental Treatment 1 Intervention

New programming strategy

Group IV: Traditional mapping, traditional follow-up Active Control 1 Intervention

Traditional follow-up plan

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

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

References

1. England pubmed.ncbi.nlm.nih.gov

Data-driven segmentation of audiometric phenotypes across a large clinical cohort. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Rationale for a Rapid Methodology to Assess the Prevalence of Hearing Loss in Population-Based Surveys. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Asymmetric sensorineural hearing thresholds in the non-noise-exposed UK population: a retrospective analysis. [2022]

4. Turkey pubmed.ncbi.nlm.nih.gov

Cataloging Existing Hearing Loss Cohort Data to Guide the Development of Precision Medicine for Sensorineural Hearing Loss: A Systematic Review of Hearing Repositories. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Association between hearing loss and deprivation among Welsh adults: a cross-sectional observational study. [2023]