None listed
Conditions
Interventions
None listed
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Pediatric patients under 18 years of age with congenital unilateral sensorineural hearing loss. 2.Based on pure-tone audiometry thresholds calculated using the six-frequency method at 500, 1000, 2000, and 4000 Hz: -Worse ear: PTA = 70 dB HL and aided speech discrimination score (SDS) = 50% at 60 dB SPL. -Better ear: PTA = 40 dB HL and SDS = 80% at 60 dB SPL. 3.If pure-tone audiometry is not feasible, auditory brainstem response (ABR) will be used: -Worse ear threshold = 90 dB nHL for patients under 1 year of age. -Worse ear threshold = 70 dB nHL for patients 1 year of age or older. 4.Insufficient hearing improvement with hearing aid use in the worse ear. 5.No contraindications to surgery or general anesthesia. 6.Voluntary written informed consent obtained after adequate explanation of the study purpose and procedures. 7.Temporal bone computed tomography (CT) confirming suitability for cochlear implantation. 8.Ability to participate in follow-up assessments for 1 year after study enrollment.
Exclusion criteria
Exclusion criteria: 1.Participants deemed unsuitable for study participation due to mental or physical conditions. 2.Individuals with acquired sensorineural hearing loss (e.g., sudden sensorineural hearing loss). 3.History of medications or systemic conditions that may affect hearing (e.g., ototoxic drugs such as chemotherapy agents). 4.Any other condition deemed inappropriate for study participation by the clinical investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective satisfaction was set as the main evaluation metric and compared pre- and postoperatively using several questionnaires (APHAB, SSQ, PEACH). Changes in speech discrimination scores were also analyzed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvements in frequency-specific hearing gain (functional gain) assessed by pure-tone audiometry, and in speech performance outcomes. | — |
Countries
Korea, Republic of
Contacts
Public ContactYe Seul Kim
Asan Medical Center
Outcome results
None listed