Efficacy of Cochlear Implantation in Adult Patients with Asymmetrical Hearing Loss: A Prospective multicenter study
- Conditions
- Diseases of the ear and mastoid process
- Registration Number
- KCT0008959
- Lead Sponsor
- Ajou University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 20
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.
-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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method uaided and aided pure tone audiometry and speech discrimination score
- Secondary Outcome Measures
Name Time Method 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)