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

Not Applicable

Recruiting

• Conditions: Hearing Disorders
• Interventions: Device: personal sound amplification product, hearing aid

• Registration Number: NCT05644106
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-10
• Primary Completion: 2021-09-10
• Study First Submitted: 2022-11-21
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-01
• Last Update Submitted: 2022-12-01
• Study First Posted: 2022-12-09
• Last Update Posted: 2022-12-09
• Study Completion: 2023-08-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Unaided	personal sound amplification product, hearing aid	-
Aided	personal sound amplification product, hearing aid	-

Primary Outcome Measures

Name	Time	Method
The hearing level threshold (decibel) after each treatment	1 month	The comparison of hearing threshold, which is calculated as mean decibel on four frequencies, among different treatments

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of