Investigation of Anatomical Correlates of Speech Discrimination

Recruiting

• Conditions: Sensorineural Hearing Loss
• Interventions: Device: Hearing Aid fitting

• Registration Number: NCT01781039
• Lead Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.

Brief Summary

Understanding speech is essential for good communication. Individuals with hearing loss and poor speech discrimination often have little success with hearing aids because amplifying sound improves audibility, but not clarity of the speech signal. The purpose of this study is to determine the relative importance of the sensory cells of the inner ear and auditory neurons on speech discrimination performance in quiet and in noise. This information may be used as a predictor of hearing aid benefit. The investigators expect to find decreased speech understanding ability resulting from both loss of sensory cells and the loss of auditory neurons.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-01-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-23
• Last Update Posted: 2022-12-27
• Primary Completion: 2026-01
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1652

Inclusion Criteria

• Normal hearing to moderate sensorineural hearing loss
• Sufficient English proficiency to complete speech discrimination testing in English

Exclusion Criteria

• Hearing loss less than a 45 dB HL pure tone average (average hearing thresholds at 500, 1000 and 2000 Hz)
• Conductive hearing loss
• Neurodegenerative disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hearing Aid fitting: MAD	Hearing Aid fitting	Microphone adaptive directionality (MAD) feature will be activated, the WDC set to linear, and the DNR minimized
Hearing Aid fitting: Negative control	Hearing Aid fitting	All hearing aid features disabled
Hearing Aid fitting: WDC	Hearing Aid fitting	Wide dynamic compression (WDC) feature will be set to target levels, the MAD feature set to omnidirectional, and the DNR minimized.
Hearing Aid fitting: DNR	Hearing Aid fitting	Digital noise reduction (DNR) set to maximum, MAD set to omnidirectional, and WDC set to linear
Hearing Aid fitting: Positive control	Hearing Aid fitting	All hearing aid features enables

Primary Outcome Measures

Name	Time	Method
Regression analysis	June 2024	Regression analysis will be used to look for a correlation between measures of sensory cell and auditory neuron survival and speech recognition performance.

Trial Locations

Locations (1)

Steward St. Elizabeth's Medical Center; 🇺🇸 Brighton, Massachusetts, United States