A Prospective Multicenter Post-Market Study Evaluating the Safety and Effectiveness of Cochlear Implantation in Adults With Single-Sided Deafness

To assess the safety and efficacy of cochlear implantation in adult patients with single-sided deafness (SSD) through a post-market approval study.

Cochlear implantation for single-sided deafness in adults appears safe and effective based on prospective multicenter post-market data; clinicians managing SSD patients should consider this evidence when counselling candidates for CI versus conventional alternatives such as CROS hearing aids or bone-anchored devices.

Prospective multicenter real-world data on cochlear implantation for single-sided deafness directly informs candidacy decisions and strengthens the evidence base for a historically under-served patient group.

1. 01Prospective, multicenter post-market design provides higher-quality real-world evidence for CI in SSD than prior retrospective series.
2. 02Study population is adults with single-sided deafness — a group where CI use has grown but guideline support has lagged.
3. 03Both safety (adverse events) and effectiveness (hearing outcomes) are primary evaluation targets.
4. 04Published in Otology & Neurotology (DOI: 10.1097/MAO.0000000000004978), a leading peer-reviewed surgical audiology journal.
5. 05Findings may support or inform regulatory and reimbursement frameworks for CI in unilateral hearing loss.

PMID

42297729

DOI

10.1097/MAO.0000000000004978.

Journal

Otology & Neurotology

Publication type

clinical_trial

Evidence level

2b

Population

Adults with single-sided deafness

Intervention

Cochlear implantation