A global patient outcomes registry: Cochlear paediatric implanted recipient observational study (Cochlear(™) P-IROS)

Area of Science:

• Audiology
• Otolaryngology
• Pediatric Health Outcomes

Background:

• Limited data exists on long-term outcomes for pediatric hearing device recipients.
• A need for large, representative population samples to assess educational placement and quality of life.

Purpose of the Study:

• To establish a prospective, multinational patient-outcomes registry for pediatric recipients of implantable hearing devices.
• To collect comprehensive data on comorbidities, device use, auditory performance, and quality of life.

Main Methods:

• The Cochlear Paediatric Implanted Recipient Observational Study (Cochlear P-IROS) is a prospective, international registry.
• Utilizes a secure web interface for electronic case report forms in multiple languages.
• Data collection includes standardized questionnaires at baseline and regular follow-ups up to 24 months and annually thereafter.

Main Results:

• The registry has recruited clinics in Australia, China, India, Indonesia, Turkey, and Vietnam.
• Aims to expand recruitment to additional countries including Japan, Russia, and South Africa.
• The registry is designed to be investigator-driven and voluntary.

Conclusions:

• The Cochlear P-IROS registry will generate valuable data for researchers, clinicians, and global stakeholders.
• Data will inform the acceptance and adoption of implantable hearing devices for hearing loss treatment.
• Findings will benefit regulators, payers, providers, policymakers, and patient families.