Status:

WITHDRAWN

Objective Measurement of Hearing Aid Benefit

Lead Sponsor:

University of Maryland, College Park

Conditions:

Auditory Perceptual Disorders

Age-related Hearing Loss

Eligibility:

All Genders

18-85 years

Phase:

NA

Brief Summary

Hearing loss is a critical health concern in the rapidly aging population, affecting approximately 22 million older individuals in the United States. Yet, only 30% of individuals who would benefit fro...

Detailed Description

Hearing loss is among the top three major health conditions in older adults and has been identified as a major modifiable risk factor for dementia. It is therefore imperative that older adults receive...

Eligibility Criteria

Inclusion

  • Aims 1 and 2 age ranges: 18-35 and 60-75
  • Aim 3 age range: 50 to 85
  • Aims 1 and 2 hearing levels: 1) Normal hearing thresholds defined as pure-tone thresholds ≤ 20 decibel (dB) hearing level (HL) from 125 to 4000 Hz and ≤ 30 dB HL at 6000 and 8000 Hz bilaterally, or 2) Mild to moderate sensorineural hearing loss defined as thresholds within 5 dB of 30 dB HL at 500 Hz, 50 dB HL at 1000 and 2000 Hz, and 60 dB HL at 4000 Hz.
  • Aim 3 hearing level: Symmetric hearing thresholds with no interaural difference ≥ 15 dB HL at ≥ 2 frequencies.
  • Intelligent Quotients ≥ 85 based on the Wechsler Abbreviated Scale of Intelligence (Psychological Corp., New York)
  • Scores ≥ 24 on the Montreal Cognitive Assessment

Exclusion

  • Neurological disorders
  • Middle ear pathology
  • Nonnative English speakers

Key Trial Info

Start Date :

June 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2027

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04431622

Start Date

June 1 2022

End Date

August 1 2027

Last Update

May 23 2022

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