N/A
N=69
Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery
Chronic Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT04864912 ↗Enrolled (actual)
69
Serious AEs
—
Results posted
Mar 2025
Primary outcome: Primary: Number and Type of Contacts With Health Care Providers — 45; 14; 5; 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Questionnaires and survey (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Type of Contacts With Health Care Providers |
45; 14; 5; 3; 2; 45 | — |
| PRIMARY Number and Type of Interventions and/or Procedures |
12; 23; 14; 65; 25; 18 | — |
| PRIMARY Number and Type of Medications and Therapies |
20; 1; 14; 3; 1; 4 | — |
| SECONDARY Hearing Performance Assessed Via an Audiogram |
56.7; 25.2 | — |
| SECONDARY Hearing Performance Assessed Via an Audiogram |
56.7; 25.2 | — |
| SECONDARY Hearing Performance Assessed Via an Audiogram |
56.7; 25.2 | — |
| SECONDARY Health Care Costs |
— | — |
| SECONDARY Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey |
41; 14; 7; 6; 24; 19 | — |
| SECONDARY Self-reported Health Status and Health Related Quality of Life Via the Health Utilities Index Mark III (HUI3) Questionnaire. |
0.7; 0.9; 0.8; 0.9; 1; 0.9 | — |
| SECONDARY Self-reported Health Related Quality of Life of Participants With COM Via the Chronic Otitis Media Outcome Test-15 (COMOT-15) Questionnaire. |
43; 29.4; 65; 46.5 | — |
| SECONDARY Self-reported Auditory Disability Via the Speech, Spatial and Qualities of Hearing Scale (SSQ-12) Questionnaire |
5.5 | — |
| SECONDARY Chronic Otitis Media Outcome Test -15 (COMOT-15) Questionnaire in German, French and Spanish |
36.8; 46.3; 45 | — |
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 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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04864912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.