Clinical research of the bone conductive hearing system.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010882

Enrollment

Registered

2013-06-06

Start date

2013-06-06

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

Bilateral conductive 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 fi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Revision tympanoplasty, ear canal stenosis or chronically draining ears where conventional hearing aids are not suitable due to poor wearability, feedback problems or poor sound quality. Congenital malformations where ear canals are absent and cannot be restored through conventional surgery.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 and 2000Hz	—

Countries

Japan

Contacts

Public ContactShin-ichi Usami

Shinshu University School of Medicine Department of Otorhinolaryngology

Outcome results

None listed

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