Clinical Trial: Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: VA Office of Research and Development

Current Primary Outcome: Words in Noise Test [ Time Frame: 2 months ]

Original Primary Outcome:

  • All outcomes will be measured at a baseline visit, and repeated 8 weeks post-treatment.
  • 1. Change in the Profile of Hearing Aid Benefit score. 2. Change in word recognition score in multitalker
  • babble.
  • 3. Change in the Satisfaction with Daily Life score.
  • 4. Change in the Communication Profile for the Hearing
  • Impaired score.


Current Secondary Outcome:

Original Secondary Outcome: 1. Change in the MOS SF36V score between baseline and 8 weeks post intervention.

Information By: VA Office of Research and Development

Dates:
Date Received: December 1, 2005
Date Started: June 2004
Date Completion:
Last Updated: March 19, 2010
Last Verified: March 2010