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

December 1, 2022 updated by: Moo Kyun, Park, Seoul National University Hospital
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Moo Kyun Park, M.D., Ph.D.
  • Phone Number: +82-2-2072-2446
  • Email: entpmk@gmail.com

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Moo Kyun Park, M.D., Ph.D.
          • Phone Number: +82-2-2072-2446
          • Email: entpmk@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Unaided
Device: personal sound amplification product, hearing aid
the device for hearing gain in sensorineural hearing loss
Active Comparator: Aided
Device: personal sound amplification product, hearing aid
the device for hearing gain in sensorineural hearing loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2021

Primary Completion (Actual)

September 10, 2021

Study Completion (Anticipated)

August 9, 2023

Study Registration Dates

First Submitted

November 21, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Estimate)

December 9, 2022

Study Record Updates

Last Update Posted (Estimate)

December 9, 2022

Last Update Submitted That Met QC Criteria

December 1, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2105-200-1223

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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