Clinical research of the bone conductive hearing system.

Clinical research of the bone conductive hearing system. - Bone conductive hearing system

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000033360

Enrollment

Registered

2018-07-11

Start date

2018-07-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

conductive hearing loss. mixed hearing loss.

Interventions

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 f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Conductive or mixed hearing loss patients with residual bone conduction thresholds in 500Hz to 4000Hz under 45 dB.

Exclusion criteria

Exclusion criteria: The patients with severe bone malformation and did not have enough setting space for bone conductive implantation. Patient who did not perform general anesthesia.

Design outcomes

Primary

Measure	Time frame
The therapeutic effects are evaluated at 12 month after the BONEBRIDGE operation, using free field audiometry. In this test, marked recovery is defined as 20dB or more recovery in the mean hearing level at the 500, 1000 2000 and 4000Hz	—

Countries

Japan

Contacts

Public ContactShin-ichi Usami

Shinshu University School of Medicine Department of Otorhinolaryngology

usami@shinshu-u.ac.jp0263-37-2666

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026