OTC HA vs HA in patients with mild-to-moderate HL

Over-the-counter hearing aid versus traditional hearing aid in patients with mild-to-moderate hearing loss: protocol for a randomized controlled, non-inferiority trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008666

Enrollment

Registered

2023-08-01

Start date

2023-08-01

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : All participants will undergo in-person assessments during three visits conducted at three-month intervals. During the first visit, the participants will be screened and randomly assi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The inclusion criteria are as follows: 1) voluntary willingness and ability to participate, 2) age 18 years or older, 3) proficiency in the Korean language, 4) hearing threshold ranging from 26 dB to 55 dB (indicating mild-to-moderate HL) based on the average of four frequencies (0.5, 1, 2, and 4 kHz) in both ears, 5) word recognition score (WRS) of 80% or higher for each ear, 6) absence of significant abnormalities in the outer ear and middle ear as determined by otoscopy, 7) type A tympanogram, and 8) no previous history of sudden HL.

Exclusion criteria

Exclusion criteria: The exclusion criteria are: 1) mental incapacity to participate in the study, and 2) prior use of HAs.

Design outcomes

Primary

Measure	Time frame
Functional gain	—

Secondary

Measure	Time frame
Speech Audiometry;Real-Ear Measurement;Questionnaires	—

Countries

Korea, Republic of

Contacts

Public ContactIlJoon Moon

Samsung Medical Center

moon.iljoon@gmail.com+82-2-3410-3579

Outcome results