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Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00261768
First received: December 1, 2005
Last updated: March 19, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention
Sensorineural Hearing Loss
 Behavioral: Digital noise reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Words in Noise Test [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 288
Study Start Date: June 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Noise reduction on
 Behavioral: Digital noise reduction

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261768

Locations
United States, Florida
VA Medical Center, Bay Pines
Bay Pines, Florida, United States, 33708
United States, Tennessee
James H. Quillen VA Medical Center
Mountain Home, Tennessee, United States, 37684
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Richard Wilson, PhD James H. Quillen VA Medical Center
  More Information

No publications provided

Responsible Party: Wilson, Richard - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00261768     History of Changes
Other Study ID Numbers: C3011R
Study First Received: December 1, 2005
Last Updated: March 19, 2010
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Aging
hearing aids
hearing loss, sensorineural
speech recognition

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013