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Efficacy of Cochlear Implantation in Adult Patients with Asymmetrical Hearing Loss: A Prospective multicenter study

Efficacy of Cochlear Implantation in Adult Patients with Asymmetrical Hearing Loss: A Prospective multicenter study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008959
Enrollment
20
Registered
2023-11-15
Start date
2023-11-06
Completion date
Unknown
Last updated
2023-12-19

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, Procedure/Surgery : A total of 20 participants will be erolled , with each institution enrolling a minimum of one and a maximum of six individuals. Prior to cochlear implant surgery, a

Sponsors

Ajou University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Adults aged 19 and older, up to 75 years of age, with asymmetric sensorineural hearing loss. -Those whose worse ear has a pure-tone average (PTA) hearing threshold of PTA = 70dB at 500, 1000, 2000, and 4000 Hz, with an aided Speech Discrimination Score (SDS) of = 50% (at 60dB), and whose better ear has a hearing threshold of 40dB = PTA <70dB, with an aided SDS of = 80% (at 60dB). -Individuals with post-lingual deafness (hearing loss acquired after language acquisition). -Those for whom significant improvement in the hearing of the deaf ear through conventional hearing aids is not expected. -No contraindications for general or local anesthesia. -Patients who voluntarily agree to participate in the clinical study and provide written consent.

Exclusion criteria

Exclusion criteria: -Individuals who are illiterate, unable to read the informed consent document, or have difficulty comprehending the clinical trial due to mental disabilities or other reasons. -Individuals with acquired hearing loss (especially if it is caused by sudden deafness, for which there is still a possibility of spontaneous recovery). -Patients receiving medication that may impact hearing (such as ototoxic drugs, including some chemotherapy agents) or those with systemic conditions that can lead to hearing impairment. -Any other cases deemed inappropriate for this trial by the clinical trial personnel's judgment.

Design outcomes

Primary

MeasureTime frame
uaided and aided pure tone audiometry and speech discrimination score

Secondary

MeasureTime frame
tinnitogram;vestibular function test;speech intelligibility test ;questionnaires(Abbreviated Profile of Hearing Aid Benefit, Korean version of Hearing Handicap Inventory for the Elderly, Tinnitus Handicap Inventory, hort form of the speech, spatial, and qualities of hearing scale, Dizziness Handicap Inventory)

Countries

Korea, Republic of

Contacts

Public ContactJungho Ha

Ajou University Hospital

jhflyflyfly@gmail.com+82-31-219-5484

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026