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OpenTrials
Completed

NCT Number: NCT04175275

Middle Ear Implant: Assessment of Satisfaction in the Medium Term

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.

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Key information

Conditions

Deafness Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Edouard Herriot

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interview patient

Other

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

Primary outcomes

  1. the abandonment rate

    Time frame: at inclusion

    calculate the rate of patient having abandonment the Use of Middle Ear Implant

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: IOM

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2019
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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