About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm
Device
All participants will complete the testing using the SEDA-HA algorithm.
Hearing aid (HA) prototype with SEDA-HA algorithm
Device
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.

Treatment groups

60 Participants

are divided into 3 treatment groups

Group A: Mild hearing lossExperimental treatment 2 interventions

Group B: Moderate hearing lossExperimental treatment 2 interventions

Group C: Severe hearing lossExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of words repeated with SEDA

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.

Time frame

Day 1 (up to 4 hours)

2

Number of words repeated without SEDA

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.

Time frame

Day 1 (up to 4 hours)

3

Number of participants who preferred SEDA-on condition

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".

Time frame

Day 30

Noise Reduction With Hearing Aids

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts