Clinical trial NCT00451503: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Hearing
Auditory rehabilitation
Middle ear implant
Surgery
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-03-23
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assessment of the middle ear implant on speech intelligibility in quiet and noise in case of failure of conventional hearing aid
timeFrame: during the study
Secondary outcomes:
measure: Assessment of the life quality of patients
timeFrame: during the study
measure: Assessment of the tolerance at 6 months postoperative of the middle ear
timeFrame: 6 months postoperative
measure: implantation
timeFrame: during the study
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hopital Beaujon
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Olivier STERKERS, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: