Evaluation of Middle Ear Implantation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Middle Ear Implants in the Therapeutic Strategy of Auditory Rehabilitation in Case of Failure of Conventional Hearing Aid|
- Assessment of the middle ear implant on speech intelligibility in quiet and noise in case of failure of conventional hearing aid [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
- Assessment of the life quality of patients [ Time Frame: during the study ] [ Designated as safety issue: No ]
- Assessment of the tolerance at 6 months postoperative of the middle ear [ Time Frame: 6 months postoperative ] [ Designated as safety issue: Yes ]
- implantation [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Study Completion Date:||June 2012|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Device: Middle Ear Implant
Other Name: surgery
Objective: The main objective of this study is to demonstrate that the middle ear implant increases the hearing in terms of speech intelligibility in quiet and noisy conditions, in patients who have no further benefit of their conventional hearing aid. The quality of life of these patients will be evaluated as well as the tolerance of the middle ear implant after 6 months.
Design of the study: 420 patients with mid or severe hearing loss will be included. They will have for 3 months the best conventional hearing aid adapted to their hearing loss. The first 84 patients who will not have a benefit of this hearing aid, will be randomised in two groups. The patients of the first group will be operated as soon as possible, the surgery of the patients of the second group will be delayed by 6 months. The whole duration of the study is 48 months.
Evaluation criteria: Audiological testing (pure-tone hearing thresholds, speech comprehension in quiet and noise), and subjective evaluation using self-assessment scales will be performed before and 6 months after the implantation in the two groups.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451503
|Clichy, France, 92110|
|Principal Investigator:||Olivier STERKERS, MD,PhD||Assistance Publique - Hôpitaux de Paris|