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Behavioural Intervention

Frequency Allocation for Hearing Loss

N/A

Recruiting

Led By Mario A. Svirsky, PhD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

Age 18 or older

No known anatomical abnormalities in either ear

Must not have

Under age 18

Non-English speaking. Participants that are Non-English speaking are excluded from this study due to the use of speech testing materials that are validated in the English language. Additionally, study team members are not equipped to appropriately score speech testing materials validated in other languages.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up behavioral visit 3 (1 month post 188 hz fat re-adaptation)

Awards & highlights

No Placebo-Only Group

Summary

"This trial will look at patients with cochlear implants who are using a new frequency allocation table to see if it can improve how well they hear, how satisfied they are with their device, and how well

Who is the study for?

This trial is for people with mixed conductive and sensorineural hearing loss, deafness, or general hearing loss who already use a cochlear implant (CI). Specific eligibility criteria are not provided, but typically participants must meet certain health standards and agree to follow the study procedures.

What is being tested?

The study tests if a new experimental frequency allocation table (FAT) set at 438 Hz can improve sound quality, satisfaction with the device, and speech perception compared to the standard FAT set at 188 Hz in experienced bimodal CI users.

What are the potential side effects?

As this trial involves non-invasive adjustments to cochlear implants rather than medication or surgery, traditional side effects are not expected. However, changes in hearing experiences such as discomfort with new sounds may occur.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My ears do not have any known structural issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I speak English fluently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ behavioral visit 3 (1 month post 188 hz fat re-adaptation)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~behavioral visit 3 (1 month post 188 hz fat re-adaptation)

This trial's timeline: 3 weeks for screening, Varies for treatment, and behavioral visit 3 (1 month post 188 hz fat re-adaptation) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT

Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT

CNC word list score while using experimental 438 Hz FAT

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experienced UsersExperimental Treatment2 Interventions

All subjects will be fit with a modified cochlear implant program ("experimental FAT") that changes which frequencies are presented to the cochlear implant. Subjects will complete a 1 month adaptation to the experimental FAT (438 Hz) and then a one month re-adaptation to the standard FAT (188 Hz). Speech perception tests and questionnaires will be collected before and after each FAT adaptation.

0 / 4Eligibility criteria met