Conductive and Mixed Hearing Loss
Conditions
Interventions
Experimental group:The Osia 2 System(consisting of the Osia 2 Sound Processor and the OSI200 Implant)
Sponsors
Boao Super Hospital
Eligibility
Sex/Gender
All
Age
5 Years to 17 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all the inclusion criteria described below to be eligible for this clinical investigation: 1. Subject with conductive hearing loss or mixed hearing loss in the ear to be implanted. Bone conduction threshold puretone average (PTA4; mean of bone conduction thresholds measured at 0.5, 1, 2 and 4 kHz) of <= 55 dB HL. 2. Subjects aged 5 to 17 years of age. 3. Subject is a fluent speaker in the language used to assess speech perception performance. 4. Parent or Legal Guardian who is willing and able to provide written informed consent for the study participant.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the exclusion criteria described below will not be eligible for this clinical investigation: 1. Unsuccessful trial with a Baha 5 Power Sound Processor on a Softband. 2. Uncontrolled diabetes as judged by the investigator. 3. Condition that could jeopardise osseointegration and/or wound healing (e.g., osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator. 4. Insufficient bone quality and quantity to support successful implant placement as judged by the investigator. 5. Previous surgery and/or implantation with any bone conduction/active device on the side to be implanted, which may jeopardise the implantation and use of the Osia 2 system, asjudged by the investigator. 6. Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator. 7. Unable to follow investigational procedures, e.g., to complete quality of life scales, or unwilling to comply with the requirements of the clinical investigation as determined by the investigator. 8. Condition with a likely negative progression and/or with expected relapses jeopardising general wellbeing and health-related quality of life as judged by the investigator. 9. Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy during the study period. 10. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. 11. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. 12. Currently participating, or participated within the last 30 days, in another interventional clinical investigation involving an investigational drug or device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in sound field threshold PTA4 (mean of sound field thresholds measured at 0.5, 1, 2 and 4 kHz).;Occurrence of Adverse Events(overall, by severity, by relatedness to device or procedure, and by seriousness) and Device Deficiencies(overall and by type) throughout the study; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in sound field threshold PTA4 (mean of sound field hearing thresholds measured at 0.5, 1, 2 and 4 kHz).;Change in speech reception threshold (SRT) for sentences in noise (50% speech perception score attained at measured signal-to-noise ratio in dB SNR).;Change in sound field thresholds measured at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz;Change in word recognition score in quiet (% correctly perceived words at 50, 65 and 80 dB SPL).;Change in the total score and subcategory scores of the Speech, Spatial and Qualities of Hearing Scale for – Parents (SSQ - P).;Change in sound field threshold PTA4 (mean of sound field thresholds measured at 0.5, 1, 2 and 4 kHz). ;Change in sound field thresholds measured at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz. ;Change in word recognition score in quiet (% correctly perceived words at, 65 dB SPL);Change in BC Direct thresholds measured at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz.; | — |
Countries
China
Contacts
Public ContactTian Xiguang
Boao Super Hospital
Outcome results
None listed