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Evaluation of Middle Ear Implantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00451503
First received: March 21, 2007
Last updated: July 6, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Hearing Loss
 Device: Middle Ear Implant

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 69
Study Start Date: March 2007
Study Completion Date: June 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
surgery
 Device: Middle Ear Implant
surgery
Other Name: surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451503

Locations
France
Hopital Beaujon
Clichy, France, 92110
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Olivier STERKERS, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00451503     History of Changes
Other Study ID Numbers: P051023
Study First Received: March 21, 2007
Last Updated: July 6, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hearing
Auditory rehabilitation
Middle ear implant
Surgery

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013