NCT02004353

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

Cochlear-Implanted Recipient Observational Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1,518 (actual)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	Cochlear® Hearing Implants	Market approved hearing implants including: Nucleus Cochlear implants, Nucleus Auditory Brainstem Implants, Cochlear Baha implants, Cochlear Acoustic Implants

Timeline

• Start date: 2011-07-01
• Primary completion: 2020-06-23
• Completion: 2020-07-31
• First posted: 2013-12-09
• Last updated: 2021-11-08
• Results posted: 2021-11-08

Locations

77 sites across 16 countries: Argentina, Austria, Belgium, Brazil, Colombia, France, Germany, Hungary, Netherlands, Poland, Portugal, Slovenia, South Africa, Spain, Sweden, Turkey (Türkiye)