None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : The patient undergo the implantation of active bone conduction hearing aid (Osia 2). The surgery will performed under the general anesthesia, about 2 hours, by otol
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Adult patients over 18 years old and under 80 years old ? Mixed hearing loss patient who have bone conduction threshold under 55dB and air-bone gap over 25dB, in pure tone audiometry ? PBmax is over 50% in speech audiometry ? The patients who have difficult to expect hearing improvement with ossiculoplasty ? The patients who can't wear a hearing aid due to not enough gain, otorrhea, and external auditory canal deformity ? The patients who are uncomfortable with the hearing aid they are wearing and want a different hearing rehabilitation method
Exclusion criteria
Exclusion criteria: ? Those who cannot read the consent form or have difficulty understanding the clinical trial due to mental status, illiterate or foreigners ? Patients with no residual hearing or with speech discrimination ability of 50% or less ? Patients who are expected to have sufficient hearing improvement with the use of general hearing aids ? Patients who need other treatment for suspected inner ear and auditory nerve pathway problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pure tone audiometry and speech audiometry with or without the active bone conduction hearing aid. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions after surgery (surgical site infection, device failure, other side effects, etc.) | — |
Countries
Korea, Republic of
Contacts
Public ContactYe Seul Kim
Asan Medical Center
Outcome results
None listed