Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial

Sensorineural Hearing Loss Clinical Trial

Official title:

Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261768
• Other study ID #: C3011R
• Status: Completed
• Phase: N/A
• First received: December 1, 2005
• Last updated: March 19, 2010
• Start date: June 2004
• Est. completion date: December 2006

Study information

• Verified date: March 2010
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Behavioral:
• Digital noise reduction

Locations

Country	Name	City	State
United States	VA Medical Center, Bay Pines	Bay Pines	Florida
United States	James H. Quillen VA Medical Center	Mountain Home	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Words in Noise Test		2 months	No