Noise Reduction With Hearing Aids
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm, Hearing aid (HA) prototype with SEDA-HA algorithm.
- Who it may be relevant to
- Registry conditions: Bilateral Sensorineural Hearing Loss. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study is to use an optimized version of the SEDA algorithm (SEDA-HA) for hearing aids to evaluate the benefit for listeners with varying degrees of hearing loss in realistic environments and evaluate its impact on speech perception and sound quality. The primary objective is to evaluate performance with and without the SEDA-HA algorithm on speech perception and speech reception tasks. The secondary objective is to evaluate performance of and experience with SEDA-HA integrated into a portable hearing aid prototype in the laboratory and in real-world situations outside the laboratory.
Interventions
- Device Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm
All participants will complete the testing using the SEDA-HA algorithm. - Device Hearing aid (HA) prototype with SEDA-HA algorithm
The study device is a non-invasive, acoustic hearing aid prototype developed by York Sound. Participants ages 18 and older will then take-home the HA prototype to begin the at home protocol for 30 days.
Primary outcome measures
- Number of words repeated with SEDA [Time frame: Day 1 (up to 4 hours)]
- Number of words repeated without SEDA [Time frame: Day 1 (up to 4 hours)]
- Number of participants who preferred SEDA-on condition [Time frame: Day 30]
Eligibility criteria
Inclusion criteria
- 16 years of age and older
- Bilateral sensorineural hearing loss. Hearing loss will be diagnosed as sensorineural by an air-bone gap of no more than 10 dB averaged across 0.5, 1, 2, and 3 kHz and Type A tympanograms.
- Mild, moderate, or severe hearing loss. Hearing loss classification will be dependent on 4-frequency pure tone average (PTA, 0.5, 1, 2 and 4kHz) in the test ear. The mild group will have a PTA of 25-40 dB HL; moderate group will have a PTA of 41-60 dB HL; the severe group will have a PTA of 61-90 dB HL.
- Be willing and able to provide consent.
Exclusion criteria
- under 16 years of age
- Participants with conductive or mixed hearing loss (i.e. have more than a 10 dB air-bone gap averaged across 0.5, 1, 2, and 3 kHz or tympanograms other than Type A)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07700043 · 25-01343 · 5SB1DC018761-05