臨床研究等提出・公開システム

Clinical research of the bone conductive hearing system.

Bone conductive hearing aid implantation.

2

From 7th August 2016 to 7th July 2020 period, 2 participants were enrolled into this study. Both patients were 30 years old male at enrollment. Case 1 suffered bilateral microtia and atresia. Case 2 suffered had unilateral atresia.

We planned to enroll 5 participants into this study, but only 2 participants were enrolled into this study. Among these two cases, one canceled to visit at 6, 12 months after BONEBRIDGE fitting by patient own convenience. So, we treated this case as protocol deviation case.

Among two cases, 1 case suffered surgical wound infection 15 days after operation. We treated this case by using antibiotics in hospitalization and the wound healed up.

primary endpoints The therapeutic effects are evaluated at 6months after the BONEBRIDGE operation, using free field audiometry. In this test, marked recovery is defined as over 20 dB improvement at the mean hearing level at the 500, 1000, 2000 and 4000Hz. Case 1 canceled to visit at 6 months after BONEBRIDGE fitting by patient own convenience. So, we treated this case as protocol deviation case. However, 9 months after BONEBRIDGE fitting he visit and received all auditory testing. His hearing level was improved from 70dB HL to 28.75dB HL 15 months after fitting. In case 2, his hearing level was improved from 72.5dB HL to 40dB 12 months after fitting. So, BONEBRIDGE was effective treatment for both cases. secondary endpoints The therapeutic effects are also evaluated at 12 months after the BONEBRIDGE operation, using Japanese speech discrimination test. In this test, marked recovery is defined as any increase than pre-ope discrimination score. Case 1 canceled to visit at 12 months and we treated this case deviation case. However, 15 months after BONEBRIDGE fitting he received all auditory testing. His speech perception score was not change from 90% to 90% 15 months after fitting. In case 2, his speech perception score was improved from 75% to 90% in12 months after fitting.

In this study, we treated one patient with congenital bilateral microtia and atresia, and one patient with congenital unilateral atresia by using BONEBRIDGE. As a result, the hearing thresholds for both patients improved dramatically after BONEBRIDGE fitting. Monosyllable perception score in noise condition was improved in one patient.

Oct. 08, 2021

No

No plan to share IPD.

https://jrct.mhlw.go.jp/latest-detail/jRCTs032190003

Suzuki Hiroaki

Shinshu University Hospital

3-1-1 Asahi, Matsumoto Nagano

youu@shinshu-u.ac.jp

Suzuki Hiroaki

Shinshu University Hospital

3-1-1 Asahi, Matsumoto Nagano

+81-263-37-2666

youu@shinshu-u.ac.jp

Complete

Aug. 07, 2016

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

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.

(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.

Both

Conductive hearing loss or Mixed hearing loss (bilateral or unilateral).

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.

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 .

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.

+81-263-37-2572

Mar. 27, 2019

none