A study on the efficacy and safety of a new bone-anchored hearing aid (Osia system)

JRCT ID: jRCTs062240076

Registered date:06/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: conductive or mixed hearing loss
• Date of first enrollment: 06/11/2024
• Target sample size: 4
• Study type: Interventional

Intervention(s)

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 and send it to the OSI20 0 implant via a digital induction link. The OSI200 implant receives the signal and converts it into vibr ations. The bone conductive terminal fixed to the OSI200 implant is screwed into the bone and osse ointegrated, and its vibrations are transmitted thro ugh the bone to the inner ear, stimulating the audi tory nerve. The implant is used permanently.

Outcome(s)

• Primary Outcome: 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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 5age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hato Naohito
• Source(s) of Monetary Support: Cochlear Japan