- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00451503
Evaluation of Middle Ear Implantation
Evaluation of Middle Ear Implants in the Therapeutic Strategy of Auditory Rehabilitation in Case of Failure of Conventional Hearing Aid
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Clichy, France, 92110
- Hôpital Beaujon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
surgery
|
surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
during the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of the life quality of patients
Time Frame: during the study
|
during the study
|
Assessment of the tolerance at 6 months postoperative of the middle ear
Time Frame: 6 months postoperative
|
6 months postoperative
|
implantation
Time Frame: during the study
|
during the study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Olivier STERKERS, MD,PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P051023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hearing Loss
-
MED-EL Elektromedizinische Geräte GesmbHCompletedHearing Loss | Hearing Loss, Sensorineural | Hearing Loss, Bilateral | Hearing Loss, Conductive | Hearing Loss, Unilateral | Hearing Loss, MixedAustria, Germany, United Kingdom
-
University of California, San FranciscoPatient-Centered Outcomes Research InstituteRecruitingHearing Loss | Hearing Loss, Sensorineural | Hearing Loss, Bilateral | Hearing Loss, Conductive | Hearing Loss, Noise-Induced | Hearing Loss, Unilateral | Hearing Loss, Mixed | Hearing Disorders in ChildrenUnited States
-
Oticon MedicalRecruitingEar Diseases | Hearing Loss, Conductive | Hearing Loss Mixed | Hearing Disability | Conductive Hearing Loss | Conductive Hearing Loss, Bilateral | Conductive Hearing Loss, UnilateralUnited Kingdom
-
Oticon MedicalNot yet recruitingSensorineural Hearing Loss, Bilateral | Sensorineural Hearing Loss, Severe | Sensorineural Hearing Loss, Profound
-
Manchester University NHS Foundation TrustUniversity of ManchesterCompletedCochlear Hearing Loss | Sensorineural Hearing Loss, BilateralUnited Kingdom
-
Oticon MedicalCompletedConductive Hearing Loss | Conductive and Sensori-neural Hearing Loss in the Same Ear | Unilateral, Profound Sensori-neural Hearing LossUnited States
-
Frequency TherapeuticsCompletedHearing Loss, Sensorineural | Presbycusis | Noise Induced Hearing Loss | Sudden Hearing LossUnited States
-
Frequency TherapeuticsCompletedHearing Loss, Sensorineural | Noise Induced Hearing Loss | Sudden Hearing LossUnited States
-
Otologic Pharmaceutics, Inc.CompletedHearing Loss | Sensorineural Hearing Loss | Noise-Induced Hearing LossUnited States
-
Otologics LLCUnknownMixed Conductive and Sensorineural Hearing Loss, Bilateral
Clinical Trials on Middle Ear Implant
-
MED-EL Elektromedizinische Geräte GesmbHCompleted
-
Otologics LLCUnknownMixed Conductive and Sensorineural Hearing Loss, Bilateral
-
Cuneyt M. AlperNational Institute on Deafness and Other Communication Disorders (NIDCD)Terminated
-
Assistance Publique - Hôpitaux de ParisMinistry of Health, FranceCompletedChronic Serous Otitis Media, Simple or UnspecifiedFrance
-
PhotoniCare, Inc.National Institute on Deafness and Other Communication Disorders (NIDCD); Carle... and other collaboratorsCompleted
-
Association Clinique Thérapeutique Infantile du...Recruiting
-
PhotoniCare, Inc.University of Pittsburgh; National Institute on Deafness and Other Communication...Completed
-
Baylor College of MedicineActive, not recruitingOtitis Media | Middle Ear Infection | Ear InfectionUnited States
-
Yuinvent Innovations Ltd.UnknownOtitis Media With Effusion
-
Bezmialem Vakif UniversityCompleted