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

Hearing Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05644106
• Other study ID #: 2105-200-1223
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2021
• Est. completion date: August 9, 2023

Study information

• Verified date: December 2022
• Source: Seoul National University Hospital
• Contact: Moo Kyun Park, M.D., Ph.D.
• Phone: +82-2-2072-2446
• Email: entpmk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 9, 2023
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Disorders
• Hearing Loss

Intervention

Device:
• personal sound amplification product, hearing aid
the device for hearing gain in sensorineural hearing loss

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The hearing level threshold (decibel) after each treatment	The comparison of hearing threshold, which is calculated as mean decibel on four frequencies, among different treatments	1 month