Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery

Cochlear

Status: Completed

Conditions: Chronic Otitis Media

Treatments: Other: Questionnaires and survey

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04864912

CBAS5780

Details and patient eligibility

About

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 at least a moderate hearing loss. The study has a retrospective part (extraction of medical chart data) and a prospective part with a survey and three questionnaires collecting data on the use of health care services, on health related quality of life and hearing performance.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design