A Clinical Trial to Evaluate the Effectiveness and Safety of Digital Auditory Rehabilitation Therapy in Patients with

Prospective, multi-center, standard treatment, parallel-controlled, randomized, single-blinded (SRS evaluator), confirmatory clinical trial to evaluate the clinical effectiveness and safety of digital rehabilitation treatment for patients with mild to moderate age-related hearing loss

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0012192

Enrollment

Registered

2026-06-29

Start date

2025-02-04

Completion date

Unknown

Last updated

2026-07-13

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 test group continued hearing aid use while additionally applying the digital therapeutic DP-DTx-002 (Hero) for approximately 30 minutes per session, 3 times per week, over 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female subjects aged 60 years or older Subjects who voluntarily provided written informed consent Subjects with mild to moderate age-related hearing loss who are currently using hearing aids Mild hearing loss: Air conduction hearing threshold =27 dB Moderate hearing loss: Air conduction hearing threshold =41 dB Subjects with conductive hearing loss =10 dB Subjects demonstrating symmetrical hearing patterns in both ears Subjects without a history of trauma, ototoxic medication use, ear diseases, noise exposure, or ear surgery Subjects without a family history of hearing loss Subjects possessing a smart device meeting the minimum requirements (Android 10.0 or higher, or iOS 11.0 or higher)

Exclusion criteria

Exclusion criteria: Subjects who have undergone cochlear implantation Subjects who have undergone bone conduction hearing aid implantation Subjects with age-related hearing loss caused by genetic factors Subjects considered unsuitable for participation by the investigator

Design outcomes

Primary

Measure	Time frame
Between-group comparison of change in Sentence Recognition Test (SRS) error rate at Week 4 compared with baseline	—

Secondary

Measure	Time frame
Between-group comparison of change in Sentence Recognition Test (SRS) error rate at Week 4 compared with baseline;Between-group comparison of change in Sentence Recognition Test (SRS) error rate at Week 4 compared with baseline;Between-group comparison of change in Sentence Recognition Test (SRS) error rate at Week 4 compared with baseline;Between-group comparison of change in Sentence Recognition Test (SRS) error rate at Week 4 compared with baseline	—

Measure

Time frame

Between-group comparison of change in Sentence Recognition Test (SRS) error rate at Week 4 compared with baseline;Between-group comparison of change in Sentence Recognition Test (SRS) error rate at Week 4 compared with baseline;Between-group comparison of change in Sentence Recognition Test (SRS) error rate at Week 4 compared with baseline;Between-group comparison of change in Sentence Recognition Test (SRS) error rate at Week 4 compared with baseline

—

Countries

Korea, Republic of

Contacts

Public Contactminji Oh

DIGITAL PHARM

minji.oh@dgtpharm.com+82-2-533-0711

Outcome results