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Evaluation of Middle Ear Implantation

NCT00451503 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2012-07-10

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Middle Ear Implant

surgery

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Olivier STERKERS, MD,PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2011-01-31
Completion
2012-06-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00451503 on ClinicalTrials.gov