chronic suppurative otitis media
Conditions
Interventions
Group 1 :Baha Attract Implantation
Sponsors
Otorhinolaryngology Hospital, The First Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 or above; 2. The ear to be implanted suffers from chronic suppurative otitis media: unilateral or bilateral conductive hearing loss; or mixed hearing loss accompanied by sensorineural hearing loss not exceeding 55 dB, that is, the mean bone conduction pure tone hearing threshold PTA4 is less than or equal to 55 dBHL (the average value measured at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz); 3. Relevant medical history (meeting one of the conditions): otitis media patients with unsatisfactory hearing after conventional middle ear surgery; otitis media patients with unsatisfactory hearing aid effect after wearing air conduction hearing aids; otitis media patients with intolerance to wearing conventional air conduction hearing aids.
Exclusion criteria
Exclusion criteria: 1. A suitable implant site for BI300 implant (4 mm or 3 mm) could not be found during surgery due to insufficient bone mass or thickness; 2. The soft tissue thickness of the planned implantation site is less than 3 mm; 3. Existing physical conditions requiring frequent magnetic resonance imaging (MRI) examinations; 4. Subject has any physical conditions that, in the judgment of the investigator, may jeopardize osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term corticosteroid use, etc.); 5. Subjects had uncontrolled diabetes, as judged by the researchers; 6. According to the judgment of the investigator, the subject has a condition that may affect the results of the study, such as retrocochlear lesions; 7. The subject has participated in the study using other drugs or medical devices; 8. Subjects had unrealistic expectations about the benefits, risks, and limitations of the surgery and implanted devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hearing evaluation (the ear with or without surgery); | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life;Skin tolerance;Imolant tolerance;Discharging situation of the ear with surgery; | — |
Countries
China
Contacts
Public ContactGuangxia Xiong
Otorhinolaryngology Hospital, The First Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed