Listening Benefits From a Hearing-aid App, a Personal Sound Amplification Product, and a Hearing Aid in Hearing-impaired Listeners
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2021
CompletedFirst Submitted
Initial submission to the registry
November 21, 2022
CompletedFirst Posted
Study publicly available on registry
December 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2023
CompletedDecember 9, 2022
December 1, 2022
1 month
November 21, 2022
December 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Unaided
ACTIVE COMPARATORAided
ACTIVE COMPARATORInterventions
the device for hearing gain in sensorineural hearing loss
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (1)
Jo S, Park MK, Seo JH, Lee KE, Han JS, Lim JH, Lee JH, Oh SH. Feasibility of a Smartphone-Based Hearing Aid App for Mild-to-Moderate Hearing Loss: Prospective Multicenter Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 Oct 5;11:e46911. doi: 10.2196/46911.
PMID: 37800887DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 21, 2022
First Posted
December 9, 2022
Study Start
August 10, 2021
Primary Completion
September 10, 2021
Study Completion
August 9, 2023
Last Updated
December 9, 2022
Record last verified: 2022-12