Bone conductive hearing aid implantation.

JRCT ID: jRCTs032190003

Registered date:02/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Conductive hearing loss or Mixed hearing loss (bilateral or unilateral).
• Date of first enrollment: 11/07/2018
• Target sample size: 5
• Study type: Interventional

Intervention(s)

The bone conductive hearing implantation is performed under general anesthesia. For the bone conductive implantation, a bed for FMT (Floating Mass Transducer) is drilled in the sinodural angle and fixed with two cortical screws. The receiver coil of the BCI is placed on the bone under the periosteum. The implant system can be activated, after the
swelling of the skin flap above the implant has reduced.

Outcome(s)

• Primary Outcome: The therapeutic effects are evaluated at 6 month after the BONEBRIDGE operation, using free field audiometry. In this test, marked recovery is defined as any recovery in the mean hearing level at the 500, 1000, 2000 and 4000Hz .
• Secondary Outcome: The therapeutic effects are also evaluated at 12 month after the BONEBRIDGE operation, using Japanese speech discrimination test. In this test, marked recovery is defined as any increase than pre-ope discrimination score.

Key inclusion & exclusion criteria

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

Include criteria

General inclusion criteria
1)Written informed consent was obtained from patient (or their guardians if they are minor).
2)The age of informed consent was 5 years old or above.

Audiometric inclusion criteria
1)Unilateral or bilateral conductive hearing loss or mixed hearing loss.
2)Patient affected ear fulfill the below bone conduction hearing thresholds.
The patients with bone conducting hearing thresholds in 500Hz to 4000Hz is under 45dBHL.

Exclude criteria

(1)The patients with severe bone malformation and did not have enough setting space for bone conductive implantation.
(2)The patients with un-compatible to general anesthesia.
(3)The Patients with post cochlear hearing loss.
(4)The patients with skin problem and did not ware audio processor.
(5)The patients who assessed unsuitable for this clinical research from medical doctor.

Related Information

• Primary Sponsor: Suzuki Hiroaki
• Secondary ID(s): UMIN000033360