Evaluation of Middle Ear Implantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00451503
Recruitment Status : Completed
First Posted : March 23, 2007
Last Update Posted : July 10, 2012
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: Middle Ear Implant Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Device: Middle Ear Implant
Other Name: surgery

Primary Outcome Measures :
  1. 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 Measures :
  1. Assessment of the life quality of patients [ Time Frame: during the study ]
  2. Assessment of the tolerance at 6 months postoperative of the middle ear [ Time Frame: 6 months postoperative ]
  3. implantation [ Time Frame: during the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00451503

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

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00451503     History of Changes
Other Study ID Numbers: P051023
First Posted: March 23, 2007    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

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

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