Middle Ear Implant: Assessment of Satisfaction in the Medium Term

Deafness Clinical Trial

— IOM  

Official title:

Middle Ear Implant: Assessment of Satisfaction in the Medium Term

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04175275
• Other study ID #: 69HCL19_0283
• Status: Completed
• Start date: March 15, 2020
• Est. completion date: May 21, 2020

Study information

• Verified date: November 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Currently, the data from the literature do not evaluate the use of the middle ear implant in implanted patients in the medium term (10 years and over) but only in the short term (1-5 years).

Based on the observation of the absence of these data, we considered it necessary to evaluate in the medium term the satisfaction of the patients carrying a middle ear implant and their rate of abandonment with a horizon of 10 to 20 years of apparatus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 21, 2020
• Est. primary completion date: May 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Patient accepting to participate to this study

• Patient having a middle ear implant since 10 - 20 years at time of inclusion

Exclusion Criteria:

• patient not dead

Related Conditions & MeSH terms

• Deafness

Intervention

Other:
• Interview patient
Interview patient without scoring about the reasons for the implant, the complications, the reasons for abandonment, the evaluation of the satisfaction

Locations

Country	Name	City	State
France	Hopital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the abandonment rate	calculate the rate of patient having abandonment the Use of Middle Ear Implant	at inclusion