conductive or mixed hearing loss middle ear, hearing loss
Conditions
Interventions
Implantation of Osia system.
The Osia system consists of an implant part (OSI200), a bone conduction terminal (BI300), and a sound processor (Osia2 sound processor). A sound processor collect sounds a
D013506
Sponsors
Hato Naohito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cases of unilateral or bilateral conductive/mixed hearing loss The average of conduction hearing level on the im planted side less than 55dB Age more than 5, and body weight more than 7kg The thickness of the bone at the implantation site more than 3mm Cases who have experience wearing optimally adj usted hearing aids Cases whose native language is Japanese Informed consent can be obtained
Exclusion criteria
Exclusion criteria: Cases whose bone quality/volume at the implantation site is expected to be insufficient to support the implant (BI300) Cases with chronic or irreversible vestibular or bal ance disorder Cases with severe progressive hearing loss Cases with bilateral retro-cochlear or central heari ng loss Skin condition is inadequate for wearing the soun d processor Sugery is expected to be difficult due to complications Cases judge to be inappropriate for participation in the clinical study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison between the average of hearing thres hold under wearing sound processor 3 months aft er surgery and the average of preoperative hearing threshold. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the following hearing results 3 and 6 months after surgery with preoperative hearing r esults -The threshold for each frequency -Speech perception test in quiet (iCI-2004) -Speech perception test in noise (iCI-2004) -subjective evaluation by questionnaire (SSQ and HHI) Surgical information Adverse events due to surgery or Osia system | — |
Contacts
Public ContactMasato Teraoka
Ehime University Hospital
Outcome results
None listed