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Clinical Trials/NCT05644106
NCT05644106
Recruiting
Not Applicable

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

Seoul National University Hospital1 site in 1 country30 target enrollmentAugust 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Disorders
Sponsor
Seoul National University Hospital
Enrollment
30
Locations
1
Primary Endpoint
The hearing level threshold (decibel) after each treatment
Status
Recruiting
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 10, 2021
End Date
August 9, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Moo Kyun, Park

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

The hearing level threshold (decibel) after each treatment

Time Frame: 1 month

The comparison of hearing threshold, which is calculated as mean decibel on four frequencies, among different treatments

Study Sites (1)

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