Related Experiment Video
Updated: Apr 22, 2026
Systematic Hearing Performance Evaluation Process for Adolescents with Cochlear Implantation at Early Ages
Published on: March 24, 2023
A global patient outcomes registry: Cochlear paediatric implanted recipient observational study (Cochlear(™) P-IROS)
Georgina Sanderson1, Thathya V Ariyaratne1, Josephine Wyss2
1Cochlear Limited, Asia Pacific Region, Macquarie University, 1 University Avenue, Sydney, NSW 2109, Australia.
Insights
A new international registry, Cochlear P-IROS, collects data on pediatric hearing device recipients. This will provide crucial long-term outcomes, educational, and quality of life data for implantable hearing devices.
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.
Background:
Currently, there is a paucity of data concerning the long-term outcomes, educational placement and quality of life of children implanted with hearing devices from large and representative samples of the population. To address this concern, a large, prospective, multicentre, multinational patient-outcomes registry for paediatric recipients of implantable hearing devices was developed. The benefits of this registry, its approach and methodology are described.
Methods/Design:
The Cochlear(™) Paediatric Implanted Recipient Observational Study (Cochlear P-IROS) is a prospective international patient-outcomes registry for children who are implanted in routine clinical practice with one or more hearing devices. The study aims to collect data on patient comorbidities, device use, auditory performance, quality of life and health-related utilities, across different types of implantable hearing devices from a range of manufacturers. Patients will be evaluated with a set of standardised and non-standardised questionnaires prior to initial device activation (baseline) and at six-monthly follow-up intervals up to 24 months and annually thereafter. The Cochlear P-IROS utilises a secure web interface to administer electronic case report forms to clinicians and families of implanted children. The web interface is currently available in five languages: English, Japanese, Korean, Mandarin and Russian. The interface also provides printable versions of the case report forms translated into 22 local languages for collection of data prior to entry online; additional languages may be added, as required. Participation in the Cochlear P-IROS registry is investigator-driven and voluntary. To date, the Cochlear P-IROS has recruited implant clinics across Australia, China, India, Indonesia, Turkey and Vietnam. The registry also aims to recruit multiple clinics in Cuba, Israel, Japan, Malaysia, Singapore, South Africa, South Korea and Russia.
Discussion:
The use of a registry such as the Cochlear P-IROS will generate valuable data to support research interests of academics and clinicians around the globe. The data generated will be relevant for a wide range of stakeholders including regulators, payers, providers, policy makers, patients and their families, each with a different perspective for the acceptance and adoption of implantable hearing devices for the treatment of hearing loss.
