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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-10-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Otitis Media

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Questionnaires and survey

Questionnaires: Health Utilities Index Mark III, Chronic Otitis Media Outcome Test-15 and Speech, Spatial, and Qualities of Hearing Scale-12 Survey: Client Service Receipt Inventory (adapted version)

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No