NCT00451503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

3.8 years

First QC Date

March 21, 2007

Last Update Submit

July 6, 2012

Conditions

Hearing Loss

Keywords

HearingAuditory rehabilitationMiddle ear implantSurgery

Outcome Measures

Primary Outcomes (1)

  • Assessment of the middle ear implant on speech intelligibility in quiet and noise in case of failure of conventional hearing aid

    during the study

Secondary Outcomes (3)

  • Assessment of the life quality of patients

    during the study

  • Assessment of the tolerance at 6 months postoperative of the middle ear

    6 months postoperative

  • implantation

    during the study

Study Arms (1)

1

EXPERIMENTAL

surgery

Device: Middle Ear Implant

Interventions

Middle Ear ImplantDEVICE

surgery

Also known as: surgery
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults patients
  • hearing loss
  • accept to participate
  • having health insurance

You may not qualify if:

  • known disease that needs MRI follow up
  • contraindication to middle ear surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Beaujon

Clichy, 92110, France

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Ossicular ProsthesisSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Olivier STERKERS, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2007

First Posted

March 23, 2007

Study Start

March 1, 2007

Primary Completion

January 1, 2011

Study Completion

June 1, 2012

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

FR(1)