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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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 pathways affect their ability to process sounds. The goal is to improve guidance and outcomes for older adults using these devices.

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 data supports the effectiveness of the treatment Diagnostic tests of auditory function and cochlear implant function for hearing loss in cochlear implantees?

Research shows that comprehensive auditory tests, like the Basic Auditory Skills Evaluation Battery, can effectively assess different aspects of hearing in cochlear implant users, providing valuable information about their auditory skills. This suggests that diagnostic tests can help evaluate and improve the function of cochlear implants in patients. ^{1 2 3 4 5}

Is it safe to undergo diagnostic auditory tests for hearing loss in cochlear implantees?

The research indicates that diagnostic auditory tests, including objective measures like auditory brainstem responses (ABR) and electrocochleography, are reliable and commonly used in both preoperative and postoperative evaluations for cochlear implantees, suggesting they are generally safe for humans. ^{3 6 7 8 9}

How does the treatment for hearing loss in cochlear implantees differ from other treatments?

This treatment is unique because it focuses on diagnostic auditory tests specifically designed for cochlear implantees, assessing various aspects of auditory perception such as speech perception, music processing, and environmental sound recognition, which are not typically covered in standard clinical testing. ^{2 6 9 10 11}

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

Eligibility Criteria

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

You have a cochlear implant in one or both ears.

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

A survey of speech and other auditory perception assessment materials used by cochlear implant centers. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Development of the Basic Auditory Skills Evaluation Battery for Online Testing of Cochlear Implant Listeners. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[The Freiburg monosyllable word test in postoperative cochlear implant diagnostics]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Nonlinguistic Outcome Measures in Adult Cochlear Implant Users Over the First Year of Implantation. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Indication criteria for cochlear implants and hearing aids: impact of audiological and non-audiological findings. [2020]

6. China pubmed.ncbi.nlm.nih.gov

[The intraoperative application of neural response telemetry with the nucleus CI24M cochlear implant]. [2006]

7. England pubmed.ncbi.nlm.nih.gov

Conversion of scores between Bamford, Kowal and Bench (BKB) sentences and Arthur Boothroyd (AB) words in quiet for cochlear implant patients. [2017]

8. Germany pubmed.ncbi.nlm.nih.gov

[Preoperative auditory evaluation and postoperative follow-up in cochlear implantees : The role of objective measures]. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Audiological assessment in the selection of cochlear implant candidates. [2019]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Electrical testing of candidates for cochlear implantation]. [2006]

11. United States pubmed.ncbi.nlm.nih.gov

Assessment of auditory skills in hearing-impaired children: theoretical foundations and a practical approach. [2006]