Personal Sound Amplification Products and Hearing Aids in patients with Hearing Loss

A Comparison of Personal Sound Amplification Products and Hearing Aids in Patients With Hearing Loss: A Randomized, Controlled, Cross-Over Clinical Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008280

Enrollment

120

Registered

2023-03-08

Start date

2021-04-27

Completion date

Unknown

Last updated

2023-04-04

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 : The study was a randomized, controlled, cross-over design with no wash-out period. All participants were assessed in person during three visits conducted at one-month intervals. At th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) age between 18 and 70 years, 2) hearing threshold between 26 dB and 55 dB (mild-to-moderate HL) based on four-frequency average (0.5, 1, 2, and 4 kHz) in both ears, 3) a word recognition score (WRS) 80% or more for each ear, 4) no significant abnormality in the outer and middle ears as assessed with otoscopy, 5) type A tympanogram, and 6) no history of sudden hearing loss.

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Primary

Measure	Time frame
Sound-field pure-tone audiometry	—

Secondary

Measure	Time frame
Sound-field word recognition socre;Korean version of the Hearing in Noise Test;Korean version Abbreviated Profile of Hearing Aid Benefit;Korean version International Outcome Inventory for Hearing Aids	—

Countries

Korea, Republic of

Contacts

Public ContactIlJoon Moon

Samsung Medical Center

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

Outcome results