Evaluation of Middle Ear Implantation

Hearing Loss Clinical Trial

Official title:

Evaluation of Middle Ear Implants in the Therapeutic Strategy of Auditory Rehabilitation in Case of Failure of Conventional Hearing Aid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451503
• Other study ID #: P051023
• Status: Completed
• Phase: N/A
• First received: March 21, 2007
• Last updated: July 6, 2012
• Start date: March 2007
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Middle Ear Implant
surgery

Locations

Country	Name	City	State
France	Hopital Beaujon	Clichy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the middle ear implant on speech intelligibility in quiet and noise in case of failure of conventional hearing aid		during the study	Yes
Secondary	Assessment of the life quality of patients		during the study	No
Secondary	Assessment of the tolerance at 6 months postoperative of the middle ear		6 months postoperative	Yes
Secondary	implantation		during the study	Yes