Diagnostic Auditory Tests for Hearing Loss in Cochlear Implantees

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, College Park

Disqualifiers: Neurological disorders, Middle-ear disorders, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why older adults with cochlear implants experience varying levels of hearing improvement. Researchers are examining factors such as normal aging, the health of hearing pathways, and implant positioning. Participants will undergo diagnostic tests of auditory function using a range of sounds, from simple tones to spoken sentences. Suitable candidates include those who have used a Cochlear-brand implant for over a year after losing their hearing later in life. A comparison group includes adults with typical hearing.

As an unphased trial, this study allows participants to contribute to valuable research that could enhance future cochlear implant outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these diagnostic tests are safe for cochlear implantees?

Research has shown that cochlear implants are safe for people of all ages with hearing loss. These implants help those with severe hearing loss hear better. Some studies indicate that common risks include technical issues, dizziness, and problems with wound healing, but these occur in only about 2-4% of cases.

The diagnostic tests under study aim to assess how well cochlear implants work and how aging affects hearing. These tests are not new treatments but methods to understand and improve the use of implants. Since they are not new medications or surgeries, they are generally considered safe. The goal is to learn more about how the implants function in older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these diagnostic auditory tests because they aim to enhance our understanding of how well cochlear implants are working in older adults. Unlike traditional methods that focus solely on external hearing aids, these tests dive deeper by assessing both auditory function and the specific performance of the cochlear implants themselves. This approach could reveal more precise information about hearing capabilities and implant effectiveness, potentially leading to more tailored treatments and improved quality of life for individuals with cochlear implants.

What evidence suggests that these diagnostic tests are effective for assessing hearing loss in cochlear implantees?

Research has shown that hearing tests can predict how well individuals with cochlear implants will hear and understand speech. In this trial, participants will undergo diagnostic tests of auditory and cochlear implant function. Computers using machine learning enhance the accuracy of these predictions. For example, one study found that individuals experienced improved hearing after receiving a cochlear implant. Additionally, tests can verify implant functionality and contribute to improved hearing over time. Long-term studies have found that individuals with cochlear implants experience better hearing and quality of life. This evidence suggests that these tests can help individuals with cochlear implants achieve optimal hearing results. ^{2 6 7 8 9}

Who Is on the Research Team?

Matthew J. Goupell, PhD

Principal Investigator

University of Maryland, College Park

Samira B. Anderson, PhD

Principal Investigator

University of Maryland, College Park

Sandra Gordon-Salant, PhD

Principal Investigator

University of Maryland, College Park

Are You a Good Fit for This Trial?

This trial is for older adults with post-lingual deafness who have been using a Cochlear-brand cochlear implant for over a year. Candidates should have normal to moderate hearing loss and must not be pregnant, use non-Cochlear implants, or have severe hearing loss or neurological disorders.

Inclusion Criteria

I became deaf after learning to speak.

You have a cochlear implant in one or both ears.

You have normal or slightly reduced hearing, or mild to moderate hearing loss.

Exclusion Criteria

I have a history of neurological disorders.

You are not able to speak using words.

Pregnant women are not eligible for the imaging portion of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Collection of baseline data including cognitive screening, history of CI device use, and imaging-based information regarding electrode placement

4 weeks

1-2 visits (in-person)

Treatment

Participants undergo various auditory and speech perception tests to assess temporal processing and speech perception

6 months

Multiple visits (in-person)

Follow-up

Participants are monitored for changes in auditory and speech perception after treatment

6 months

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Diagnostic tests of auditory function
• Diagnostic tests of cochlear implant function

Trial Overview The study tests how aging, health of auditory pathways, and the placement of cochlear implant electrodes affect speech perception in older users. It involves diagnostic tests on cochlear implant function and auditory processing using various sounds.

How Is the Trial Designed?

Group I: Enrolled Participants - Older adults with cochlear implants Experimental Treatment 1 Intervention

Individuals who already use at least one cochlear implant.

Group II: Enrolled Participants - Adults with typical hearing Experimental Treatment 1 Intervention

Control group to provide baseline or comparison data

Who Is Running the Clinical Trial?

University of Maryland, College Park

Lead Sponsor

Trials

163

Recruited

46,800+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12101302/

Prediction of Auditory Performance in Cochlear Implants ... Machine learning algorithms for predicting hearing and speech performance of individuals with hearing loss, optimization studies in cochlear ...

2. withpower.com withpower.com/trial/phase-hearing-loss-7-2022-f40bc

Diagnostic Auditory Tests for Hearing Loss in Cochlear ... This trial studies older adults using cochlear implants to understand why some benefit more than others. It looks at how aging and the health of hearing ...

3. nature.com nature.com/articles/s41746-025-01733-9

A systematic review of machine learning approaches in ... This systematic review critically examines the current literature on the application of machine learning (ML) techniques for predicting CI outcomes.

4. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2023.1281884/full

Outcomes of cochlear implantation in 75 patients with ... After four years of implantation, the average hearing threshold improved from 97.75 dB to 30 dB after implantation of half years. The CAP score ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1808869424000387

Cochlear implantation outcomes in children with multiple ... In addition, 20 out of 31 children (64.5%) have achieved verbal communication after implantation. The mean PEACH score in quiet was significantly better than in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7851969/

Cochlear Implantation: Diagnosis, Indications, and Auditory ... The more common complications of the procedure, with a probability of 2–4% each, are technical implant defects, dizziness, and wound-healing disturbances.

7. aetna.com aetna.com/cpb/medical/data/1_99/0013.html

Cochlear Implants and Auditory Brainstem Implants Aetna considers an auditory brainstem implant (ABI) medically necessary in members 12 years of age or older who have lost both auditory nerves due to disease.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1808869424001277

Brazilian Society of Otology task force – cochlear implant ... CI is a safe device for auditory rehabilitation of patients with severe-to-profound hearing loss. In recent years, indications for unilateral hearing loss and ...

9. anthem.com anthem.com/medpolicies/abc/active/gl_pw_d083867.html

CG-SURG-81 Cochlear Implants and Auditory Brainstem ... This document addresses cochlear implants, auditory brainstem implants, and replacement or upgrade of speech processor and controller components.