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Cochlear Implant Programming for Hearing Loss

N/A

Recruiting

Led By Julie Arenberg

Research Sponsored by Massachusetts Eye and Ear Infirmary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ADULTS: Adult at least 18 years old, native speakers of American English, wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 5 weeks, and 10 weeks after the intervention

Awards & highlights

Study Summary

This trial aims to improve cochlear implant outcomes for adults & children by understanding how they affect the auditory system & testing new methods of programming. Advancing our knowledge of how the deafened auditory system develops will improve hearing outcomes.

Who is the study for?

This trial is for children and adults with severe hearing loss who have cochlear implants from specific manufacturers. Adults must be at least 18, native English speakers, while children can participate from 6 months old. Participants cannot join if they're unable to consent or meet certain protocol criteria like age of hearing loss onset.Check my eligibility

What is being tested?

The study aims to understand how cochlear implants affect auditory development and test new programming methods for better speech perception in users. It involves cognitive assessments, threshold and psychophysical testing, speech tests, and telemetry recordings over time.See study design

What are the potential side effects?

Since this trial focuses on testing procedures rather than medications, traditional side effects are not a concern. However, participants may experience fatigue or discomfort during the extensive testing process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 or older, speak American English, and wear a cochlear implant from Advanced Bionics, Cochlear, or MED-EL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, and weekly for 10 weeks after the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, and weekly for 10 weeks after the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and weekly for 10 weeks after the intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in phoneme discrimination scores

Changes in sentence recognition scores

Changes in speech-gap detection thresholds

+4 more

Secondary outcome measures

Age

Hearing quality of life (HEARQL) scores

Infant-Toddler Meaningful Auditory Integration Scale (ITMAIS) scores

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention to assess CIExperimental Treatment5 Interventions

To develop new programming strategies for individuals that will improve performance for a wider range of cochlear implant people

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonOTHER

1,741 Previous Clinical Trials

1,847,566 Total Patients Enrolled

3 Trials studying Hearing Loss

847 Patients Enrolled for Hearing Loss

Massachusetts Eye and Ear InfirmaryLead Sponsor

106 Previous Clinical Trials

12,749 Total Patients Enrolled

7 Trials studying Hearing Loss

421 Patients Enrolled for Hearing Loss

Boston Children's HospitalOTHER

761 Previous Clinical Trials

5,579,730 Total Patients Enrolled

Media Library

Cochlear Implant Electrode-neuron Interfaces Clinical Trial Eligibility Overview. Trial Name: NCT05867173 — N/A

Hearing Loss Research Study Groups: Intervention to assess CI

Hearing Loss Clinical Trial 2023: Cochlear Implant Electrode-neuron Interfaces Highlights & Side Effects. Trial Name: NCT05867173 — N/A

Cochlear Implant Electrode-neuron Interfaces 2023 Treatment Timeline for Medical Study. Trial Name: NCT05867173 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are participating in this trial?

"Affirmative, the information found on clinicaltrials.gov suggests that the recruiting of participants is still underway for this medical trial. It was first posted in May 2019 and last updated four years later, with a goal to source 200 patients from 1 site."

Answered by AI

Is this research project currently accepting participants?

"Affirmative. The records available on clinicaltrials.gov validate that this investigation is still recruiting individuals, with the original posting being dated May 14th 2019 and updated as recently as May 17th 2023. 200 participants are needed from a single site to fulfil the criteria of this trial."

Answered by AI

What are the primary goals that this medical research aims to achieve?

"This clinical trial's primary purpose is to measure the efficacy of a proposed programming strategy through examination at Baseline. Secondary criteria include assessment of Infant-Toddler Meaningful Auditory Integration Scale (ITMAIS), Macarthur-Bates vocabulary inventory scores, and Hearing Quality Of Life (HEARQL) scores."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces

Julie G. Arenberg, CCC-A 2022. "Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05867173.

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