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Completed

NCT Number: NCT00261768

Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial

The purpose of this study is to see if noise reduction programs in digital hearing aids help patients hear better than hearing aids without these programs. We also want to know if we can predict how successful patients will be with hearing aids.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center, Bay Pines, Bay Pines, Florida, United States

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About this study

The first goal of this project is to examine the efficacy of digital hearing aids incorporating three noise reduction strategies (i.e., directional microphones alone vs. directional microphones with DSP noise reduction algorithm 1 vs. directional microphones with DSP noise reduction algorithm 2) in terms of both speech understanding outcomes and functional outcomes. The second goal is to identify individual characteristics that are predictive of successful functional outcomes with hearing aids.

This study employs a multi-site, randomized, blinded, 2x2 factorial parallel group design. Three hundred subjects will be studied at three VA Medical Centers (Mountain Home, TN; Bay Pines, FL; and Los Angeles, CA) over a period of three years.

Objective (word recognition ability and performance with degraded speech stimuli) subjective (self-assessment questionnaires, personality and depression assessments) and cost-effectiveness assessments will be measured for 4 randomized treatment groups receiving different digital hearing aid technology. Subjects will be randomly assigned to wear hearing aids with directional microphones alone or directional microphones with noise reduction algorithm 1 or directional microphones with noise reduction algorithm 2 for a period of 8 weeks. Subjects will complete post-testing after 8 weeks of hearing aid use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult onset sensorineural hearing loss
  • English as the first language
  • bilateral symmetrical sensorineural hearing loss
  • Patient is a candidate for directional microphone technology.
  • average audiometric thresholds for 500, 1000, 2000, 3000, and 4000 Hz no better than 25-dB HL in either ear.
  • no history of hearing aid use in the past 10 years
  • appropriate cognitive skills to participate in the study as determined by a passing score on the Mini Mental Scale.
  • Patient has a local telephone and address.

Exclusion criteria

  • evidence of outer ear, middle ear, or retrocochlear pathology
  • any threshold from 500 to 2000 Hz exceeds 70-dB HL
  • known neurological or psychiatric disorders as determined by chart review
  • known comorbid diseases that would prevent completion of the study as determined by chart review
  • visual impairment that would interfere with reading the questionnaires

Treatment and study plan

Digital noise reduction

Behavioral

Primary outcomes

  1. Words in Noise Test

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Dec 5, 2005
Registry last updated
Mar 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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