Middle Ear Implant: Assessment of Satisfaction in the NCT04175275

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT04175275
Other study ID #	69HCL19_0283
Secondary ID
Status	Completed
Phase
First received
Last updated
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
Health authority
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

Study Design

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

See also
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Completed	`NCT01400178` - Cochlear Implants in Post-lingually Children: Results After 10 Years	N/A
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Active, not recruiting	`NCT03352154` - Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants	N/A
Recruiting	`NCT04495660` - Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS	N/A

Middle Ear Implant: Assessment of Satisfaction in the Medium Term

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Country where clinical trial is conducted

Outcome