Bilateral Sensorineural Hearing Loss
Conditions
Keywords
Hearing aid, Hearing loss, Cochlear Implant, CI
Brief summary
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
DEVICESpeech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm
All participants will complete the testing using the SEDA-HA algorithm.
DEVICEHearing 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.
Sponsors
NYU Langone Health
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of words repeated with SEDA | Day 1 (up to 4 hours) | Participant will listen to an IEEE (IEEE Subcommittee, 1969) sentence and repeat all the words they hear. The process will be repeated for 10 sentences in each listening condition. Background noise will consist of one of five noise types (Babble, White Gaussian, Speech-Shaped, Restaurant, and Traffic) and one of five SNRs (-4, -2, 0, 3, and 6 dB). Each listening condition will be evaluated with and without SEDA, in an order that is randomized across participants. |
| Number of words repeated without SEDA | Day 1 (up to 4 hours) | Participant will listen to an IEEE (IEEE Subcommittee, 1969) sentence and repeat all the words they hear. The process will be repeated for 10 sentences in each listening condition. Background noise will consist of one of five noise types (Babble, White Gaussian, Speech-Shaped, Restaurant, and Traffic) and one of five SNRs (-4, -2, 0, 3, and 6 dB). Each listening condition will be evaluated with and without SEDA, in an order that is randomized across participants. |
| Number of participants who preferred SEDA-on condition | Day 30 | The hearing aid prototype will feature two buttons "P1" and "P2", which correspond to the SEDA-on and SEDA-off conditions. Subjects will be asked if they prefer "P1" or "P2". |
Countries
United States
Contacts
CONTACTNatalia Stupak
CONTACTDavid Landsberger, Ph.D.
PRINCIPAL_INVESTIGATORDavid Landsberger, Ph.D.
NYU Langone Health
Outcome results
None listed