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Benefits and efficacy of cochlear implant system in subjects with unilateral or asymmetrical acquired sensorineural severe-to-profound hearing loss

Benefits and efficacy of cochlear implant system in subjects with unilateral or asymmetrical acquired sensorineural severe-to-profound hearing loss

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021885
Enrollment
Unknown
Registered
2019-03-14
Start date
2019-04-01
Completion date
Unknown
Last updated
2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acquired unilateral or asymmetrical severe-to-profound hearing loss

Interventions

Hearing loss:Cochlear Implant

Sponsors

Chinese University of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. No previous implant/BAHA experience in the ear to be implanted; 2. 6 years of age or older; 3. Severe-to-profound sensorineural hearing loss (pure-tone average thresholds > 80 dB HL at 500, 1000 and 2000 Hz) in the ear to be implanted. Prelingual or Postlingual onset of severe to profound unilateral hearing loss. 4. Arm 1: Duration of deafness = 10 years; 5. Arm 2: Duration of deafness > 10 but = 20 years; 6. Marginal hearing aid benefit, defined as a monosyllabic word recognition score of = 50% in the best-aided condition for the ear to be implanted; 7. Cantonese proficiency; 8. Willingness to participate in all scheduled procedures outlined in the protocol.

Exclusion criteria

Exclusion criteria: 1. Unilateral deafness resulting from non-intact auditory nerve; 2. Cochlear malformation or obstruction that would preclude full insertion of electrode array; 3. Presence of additional disabilities that would prevent or interfere with participation in the required study procedures; 4. Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures; 5. Indication for central auditory lesion or compromised auditory nerve.

Design outcomes

Primary

MeasureTime frame
Word (Disyllabic) and sentence (CHINT sentences) at 65 dB SPL in soundfield;

Countries

China

Contacts

Public ContactTong Michael Chi-fai

Chinese University of Hong Kong

mtong@ent.cuhk.edu.hk+852 35052628

Outcome results

None listed

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