Back to resultsListening Benefits From a Hearing-aid App, a Personal Sound Amplification Product, and a Hearing Aid in Hearing-impaired Listeners
Primary Purpose
Hearing Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
personal sound amplification product, hearing aid
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Disorders focused on measuring Hearing aid, Personal sound amplification product, Hearing aid application, Hearing loss
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
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Unaided
Aided
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05644106
First Posted
November 21, 2022
Last Updated
December 1, 2022
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05644106
Brief Title
Listening Benefits From a Hearing-aid App, a Personal Sound Amplification Product, and a Hearing Aid in Hearing-impaired Listeners
Official Title
Listening Benefits From a Hearing-aid App, a Personal Sound Amplification Product, and a Hearing Aid in Hearing-impaired Listeners
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
August 9, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Disorders
Keywords
Hearing aid, Personal sound amplification product, Hearing aid application, Hearing loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Unaided
Arm Type
Active Comparator
Arm Title
Aided
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
personal sound amplification product, hearing aid
Intervention Description
the device for hearing gain in sensorineural hearing loss
Primary Outcome Measure Information:
Title
The hearing level threshold (decibel) after each treatment
Description
The comparison of hearing threshold, which is calculated as mean decibel on four frequencies, among different treatments
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moo Kyun Park, M.D., Ph.D.
Phone
+82-2-2072-2446
Email
entpmk@gmail.com
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moo Kyun Park, M.D., Ph.D.
Phone
+82-2-2072-2446
Email
entpmk@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Listening Benefits From a Hearing-aid App, a Personal Sound Amplification Product, and a Hearing Aid in Hearing-impaired Listeners
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