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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for programming cochlear implants to determine if fewer follow-up visits can still yield good results. It focuses on individuals who have recently selected Cochlear Americas implants for surgery. The researchers aim to discover if "population mean mapping" (a method to fine-tune the implant for many people) can maintain steady hearing improvements while reducing the number and duration of doctor visits. This trial suits adults who became deaf after learning to speak, are receiving a new Cochlear Americas implant, and can participate in simple hearing tests. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could simplify care for future patients.

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.

What prior data suggests that this new programming strategy for cochlear implants is safe?

Research has shown that a new programming method, called population mean mapping, is designed to help cochlear implant users start hearing more easily. Studies have found that this method enables users to begin hearing more quickly with their implants, which can be beneficial.

While this research does not specifically address safety, it focuses on making the programming process more efficient and effective, rather than on the safety of the implant itself. Cochlear implants have already been approved for use, and this study aims to improve the programming process after the implant is in place.

This suggests that the treatment is likely well-tolerated, as it builds on technology and procedures already in use. The new mapping method seeks to enhance convenience without compromising safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Population Mean Mapping for hearing loss because it offers a fresh approach to managing the condition. Unlike traditional hearing aid fitting methods that require numerous follow-up visits to fine-tune settings for each individual, this method uses a new programming strategy that could reduce those visits. This technique aims to streamline the process, making hearing aids more accessible and convenient for patients. By potentially minimizing follow-up appointments, it could also lead to quicker adjustments and improved user satisfaction with hearing aids.

What evidence suggests that this trial's treatments could be effective for hearing loss?

Research has shown that a method called population mean mapping, which participants in this trial may receive, can make cochlear implant programming more efficient without affecting patient results. One study found that this method helps maintain stable hearing outcomes while reducing the number of follow-up visits needed. This approach allows for faster activation of the cochlear implant, easing the initial hearing experience for patients. It performs similarly to traditional methods but with greater efficiency. Additionally, it sets sound levels to align with well-established practices, ensuring a reliable hearing experience. ^{3 6 7 8 9}

Who Is on the Research Team?

Julie Arenberg

Principal Investigator

Massachusetts Eye and Ear

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. journals.lww.com journals.lww.com/otology-neurotology/fulltext/9900/assessment_of_population_mean_maps_for_activation.942.aspx

Assessment of Population Mean MAPs for Activation of... The objective of this study was to compare audiological outcomes and MAP levels between CI recipients whose devices were programmed at ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06960616

Improving Clinical Efficiency by Reducing Scheduled ... 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 ...

3. pronews.cochlear.com pronews.cochlear.com/clinical-programming-series-population-mean/

Clinical Programming Series: Population Mean Population mean creates an easier activation experience for patients and enables a quicker Go Live. It allows the patient's first experience hearing through ...

4. withpower.com withpower.com/trial/phase-deafness-1-2024-32fea

Population Mean Mapping for Hearing Loss 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12208637/

Setting Upper Stimulation Levels in Adult Cochlear Implant ... This study investigated the relationship between USLs obtained via population mean and eSRTs, the latter being an evidence-based method for setting USLs. The ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12321882/

Global impact of Occupational Noise-Induced Hearing Loss ... The data were sourced from the Global Burden of Disease (GBD) study conducted in 2021. A Joinpoint regression model was employed to calculate ...

7. 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.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3277688/

Occupational noise exposure assessment using O*NET ... We found a significant dose–response relationship of O*NET noise scores with hearing loss and noise notch in NHANES, confirming that O*NET scores would be ...

9. nature.com nature.com/articles/s41597-025-05884-y

The Oldenburg Hearing Health Record (OHHR) It contains data from 581 adults aged 18–86 years (255 females; mean age = 67.31 years; SD = 11.93) with varying degrees of hearing loss. Data ...