Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear (IROS)

Cochlear

Status: Terminated

Conditions: Hearing Loss

Treatments: Device: Cochlear® Hearing Implants

Study type: Observational

Funder types: Industry

Identifiers

NCT02004353

CEL 5277

Details and patient eligibility

About

The purpose of this study is to collect patient related benefit data following treatment for permanent hearing loss with a hearing implant from the company Cochlear over a period of 2 years post treatment.

Assessment of benefits is based on standard questionnaires of hearing ability and quality of life in general.

Full description

The clinical investigation is designed as a prospective repeated measures longitudinal study with intra-subject controls, using a selection of subjective evaluation tools to assess patient related benefits from hearing implant treatment of permanent hearing loss.

Clinically standard self-assessment scales, threshold measures and a general hearing history profile questionnaires for the clinician and implant recipient are made available for selection through an interface to a central electronic platform.

The registry is aimed at collection of data for patients who have already made the decision together with their implant centre clinician for an implant device from the company Cochlear.

Patients are approached for registry participation following implant by the caring clinician on a consecutive and voluntary basis and on condition of signing the patient informed consent.

Monitoring of data entry is included through automated reminders via e-platform and through inherent audit trail.

Enrollment: 1,518 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Post-lingually deafened adults and adolescents who are newly implanted AND prior to first switch-on of their external device
• Unilateral, bilateral simultaneous recipients of any implant device(s) available with market approval from the company Cochlear®
• Children 10 years or older and in accordance with local regulations and product labelling
• Mentally capable to respond to self-administered assessment scales
• Willingness to participate and sign the Patient Informed Consent form

Exclusion criteria

• Individuals excluded from participation in a registry according to national or local regulations

Trial design

1,518 participants in 1 patient group

Cochlear® Hearing Implants, hearing loss

Description:

Implanted Adolescents and Adults with permanent hearing loss

Treatment:

Device: Cochlear® Hearing Implants