Listening Benefits From a Hearing-aid App, a Personal Sound Amplification Product, and a Hearing Aid in Hearing-impaired Listeners

Seoul National University

Status: Enrolling

Conditions: Hearing Disorders

Treatments: Device: personal sound amplification product, hearing aid

Study type: Interventional

Funder types: Other

Identifiers

NCT05644106

2105-200-1223

Details and patient eligibility

About

Interest and demand for sound amplifiers are increasing due to the burden of purchasing hearing aids and technological advances in healthcare products, and the demand is expected to increase rapidly. For sensorineural hearing loss patients, who are subject to wearing hearing aids, it aims to compare the effect of hearing aid application and personal sound amplification product (PSAPs) compared to the hearing aids

Enrollment: 30 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults over the age of 20 who speak Korean as their mother tongue and have no mental or physical limitations in conducting test.
2. Hearing loss patients with a hearing threshold of 26 dB or higher in the four frequency (0.5, 1, 2, 4 kHz)
3. Those who do not have a history of neurological disease, cognitive disorder, learning disorder, or language disorder at the time of recruitment

Exclusion criteria

1. In case that communication is difficult, equipment cannot be handled, or it is difficult to cooperate with the inspection
2. Acoustic nerve lesions or central nervous system disease
3. Those suspected of having false hearing loss
4. Those who have secondary benefits related to clinical trials

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Unaided

Active Comparator group

Treatment:

Device: personal sound amplification product, hearing aid

Aided

Active Comparator group

Treatment:

Device: personal sound amplification product, hearing aid