An observational study that evaluates the improvements in auditory performance (hearing) and health related benefits (quality of life) achieved by children using implantable hearing devices: Cochlear Paediatric Implanted Recipient Observational Study (Cochlear P-IROS)

A global prospective observational study (patient registry) to assess the effectiveness of implantable hearing devices in children implanted at < 10 years of age, in their everyday life.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12613000558729

Acronym

Cochlear P-IROS

Enrollment

1138

Registered

2013-05-17

Start date

2013-02-01

Completion date

2021-08-31

Last updated

2023-05-22

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

Conditions

None listed

Brief summary

To address these reported gaps in the literature regarding the clinical efficacy of implantable hearing devices, a global prospective observational study (a patient registry) has been developed to assess the effectiveness of hearing habitation with the aid of implantable hearing devices in infants and young children up to the age of 10 years, in their everyday life.

Interventions

The use of cochlear implants, bone conduction implants, other implantable hearing devices in the treatment of hearing loss , over a period of 2 years (minumum)- 5 years (maximum) post implantation.

Eligibility

Sex/Gender

All

Age

0 to 10 Years

Healthy volunteers

Inclusion criteria

Children < 10 years of age at time of first implantation; Received an regulatory approved implantable hearing device/s;

Exclusion criteria

Prior experience with an implantable hearing device Implantable devices not yet approved for sale by regulatory authority

Outcome results