Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial

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Brief Title

Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial

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 Description

      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.
    


Study Type

Interventional


Primary Outcome

Words in Noise Test


Condition

Sensorineural Hearing Loss

Intervention

Digital noise reduction

Study Arms / Comparison Groups

 1
Description:  Noise reduction on

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

288

Start Date

June 2004

Completion Date

December 2006

Primary Completion Date

December 2006

Eligibility Criteria

        Inclusion Criteria:

          1. adult onset sensorineural hearing loss

          2. English as the first language

          3. bilateral symmetrical sensorineural hearing loss

          4. Patient is a candidate for directional microphone technology.

          5. average audiometric thresholds for 500, 1000, 2000, 3000, and 4000 Hz no better than
             25-dB HL in either ear.

          6. no history of hearing aid use in the past 10 years

          7. appropriate cognitive skills to participate in the study as determined by a passing
             score on the Mini Mental Scale.

          8. Patient has a local telephone and address.

        Exclusion Criteria:

          1. evidence of outer ear, middle ear, or retrocochlear pathology

          2. any threshold from 500 to 2000 Hz exceeds 70-dB HL

          3. known neurological or psychiatric disorders as determined by chart review

          4. known comorbid diseases that would prevent completion of the study as determined by
             chart review

          5. visual impairment that would interfere with reading the questionnaires
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Richard Wilson, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00261768

Organization ID

C3011R



Study Sponsor

US Department of Veterans Affairs


Study Sponsor

Richard Wilson, PhD, Principal Investigator, James H. Quillen VA Medical Center


Verification Date

March 2010