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

NCT ID: NCT05644106

Last Updated: 2022-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-10

Study Completion Date

2023-08-09

Brief Summary

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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

Detailed Description

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Conditions

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Hearing Disorders

Keywords

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Hearing aid, Personal sound amplification product, Hearing aid application, Hearing loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Unaided

Group Type ACTIVE_COMPARATOR

personal sound amplification product, hearing aid

Intervention Type DEVICE

the device for hearing gain in sensorineural hearing loss

Aided

Group Type ACTIVE_COMPARATOR

personal sound amplification product, hearing aid

Intervention Type DEVICE

the device for hearing gain in sensorineural hearing loss

Interventions

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personal sound amplification product, hearing aid

the device for hearing gain in sensorineural hearing loss

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Moo Kyun, Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Moo Kyun Park, M.D., Ph.D.

Role: CONTACT

Phone: +82-2-2072-2446

Email: [email protected]

Facility Contacts

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Moo Kyun Park, M.D., Ph.D.

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37800887 (View on PubMed)

Other Identifiers

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2105-200-1223

Identifier Type: -

Identifier Source: org_study_id