Sensorineural Hearing Loss Clinical Trial
Official title:
Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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