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

Hearing Loss Clinical Trial

Official title:
Cochlear-Implanted Recipient Observational Study

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02004353
Study type Observational [Patient Registry]
Source Cochlear
Contact
Status Terminated
Phase
Start date July 2011
Completion date July 31, 2020
View Details
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