Back to resultsEvaluation of Middle Ear Implantation
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Middle Ear Implant
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Hearing, Auditory rehabilitation, Middle ear implant, Surgery
Eligibility Criteria
Inclusion Criteria:
- adults patients
- hearing loss
- accept to participate
- having health insurance
Exclusion Criteria:
- known disease that needs MRI follow up
- contraindication to middle ear surgery
Sites / Locations
- Hopital Beaujon
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
surgery
Outcomes
Primary Outcome Measures
Assessment of the middle ear implant on speech intelligibility in quiet and noise in case of failure of conventional hearing aid
Secondary Outcome Measures
Assessment of the life quality of patients
Assessment of the tolerance at 6 months postoperative of the middle ear
implantation
Full Information
NCT ID
NCT00451503
First Posted
March 21, 2007
Last Updated
July 6, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00451503
Brief Title
Evaluation of Middle Ear Implantation
Official Title
Evaluation of Middle Ear Implants in the Therapeutic Strategy of Auditory Rehabilitation in Case of Failure of Conventional Hearing Aid
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The middle ear implant are used for patients with mild to severe sensorineural hearing loss, who cannot benefit from conventional hearing aids because of medical reasons such as chronic external otitis or external skin irritation. The device is also available for patients who are dissatisfied with the conventional hearing aids because of poor sound quality, feedback or occlusion of the ear canal. To date, more than 1500 patients have been implanted in Europe and about more than 600 patients in France. The aim of the present study is to compare in a randomized study the performances of the system to those of the conventional hearing aid in patients with similar degree of hearing loss.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Hearing, Auditory rehabilitation, Middle ear implant, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
surgery
Intervention Type
Device
Intervention Name(s)
Middle Ear Implant
Other Intervention Name(s)
surgery
Intervention Description
surgery
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Assessment of the life quality of patients
Time Frame
during the study
Title
Assessment of the tolerance at 6 months postoperative of the middle ear
Time Frame
6 months postoperative
Title
implantation
Time Frame
during the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults patients
hearing loss
accept to participate
having health insurance
Exclusion Criteria:
known disease that needs MRI follow up
contraindication to middle ear surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier STERKERS, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Middle Ear Implantation
We'll reach out to this number within 24 hrs