Status:
COMPLETED
Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery
Lead Sponsor:
Cochlear
Collaborating Sponsors:
QbD Clinical
Suministros Hospitalarios Medical Group
Conditions:
Chronic Otitis Media
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this multicentre study is to evaluate the standard of care of participants diagnosed with Chronic Otitis Media that have already gone through a first middle ear surgery but still have...
Eligibility Criteria
Inclusion
- Adult subjects, 18 years or older.
- Subjects with conductive or mixed hearing loss.
- Subjects with historically documented diagnosis of Chronic Otitis Media (COM) with or without cholesteatoma in the operated ear.
- Subjects who have undergone primary tympanoplasty type I-V to improve hearing between 2010-2016.
- Subjects with a Pure Tone Average (PTA)4 air-bone gap ≥30 decibels (dB) OR PTA4 air-bone gap between 25-30 dB with an air conduction threshold PTA4 ≥40 dB HL within 12 months after primary tympanoplasty in the operated ear.
- Subjects who have been recommended by their health care professional to try a hearing aid to improve hearing in the operated ear.
- Pre-op audiogram, maximum 1 year prior to the primary tympanoplasty, and post-op audiogram for the primary tympanoplasty are available.
- Aided audiogram, unaided if no hearing device is used, available between 2018 and the point of enrolment.
- Subjects are fluent in the language used for study questionnaires: German, French, Spanish.
- Subjects are willing and able to provide written informed consent. For France: subjects do not oppose to participate in the study.
- Medical Record data is available throughout the defined data search period, from primary tympanoplasty to point of enrolment.
Exclusion
- Subjects are unable or unwilling to comply with the requirements of the study as determined by the investigator.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this study.
- For France only:
- Subjects who are not affiliated to social security.
- Subjects who are under legal protection.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 9 2023
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT04864912
Start Date
February 1 2022
End Date
October 9 2023
Last Update
March 7 2025
Active Locations (6)
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1
Hôpital Bicêtre, Hôpitaux universitaires Paris Sud AP-HP
Le Kremlin-Bicêtre, France, 94275
2
ENT department - Bâtiment Pierre Paul Riquet - Hôpital Purpan
Toulouse, France, 31059
3
Universitätsklinik für Hals-, Nasen und Ohrenheilkunde
Freiburg im Breisgau, Germany, 79106
4
Hals-, Nasen- und Ohrenklinik, Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120