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Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial

Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00261768
Enrollment
288
Registered
2005-12-05
Start date
2004-06-30
Completion date
2006-12-31
Last updated
2010-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensorineural Hearing Loss

Keywords

Aging, hearing aids, hearing loss, sensorineural, speech recognition

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.

Interventions

BEHAVIORALDigital noise reduction

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Words in Noise Test2 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026