VSB for unilateral conductive or mixed hearing loss

JRCT ID: jRCTs032190002

Registered date:02/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Unilateral conductive hearing loss or Mixed hearing loss
• Date of first enrollment: 24/08/2018
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Set the flowing mass transducer of VSB system on the round window by operation.

Outcome(s)

• Primary Outcome: The therapeutic effects are evaluated at 12 month after VSB surgery using free field audiometry. 20dB or more threshold recovery regarded as effective cases.
• Secondary Outcome: Inner and after surgery safeness and adverse event in the observation period.

Key inclusion & exclusion criteria

• Age minimum: >= 4age 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 4 years old or above.

Audiometric inclusion criteria
1)Unilateral conductive hearing loss or mixed hearing loss.
2)Patient fulfill the below bone conduction hearing thresholds.
500Hz:45dB or less
1000Hz:50dB or less
2000Hz:65dB or less
4000Hz:65dB or less

Exclude criteria

1) Patients with highly malformation of cochlear or temporal bones.
2) Patients do not use general anesthesia.

Related Information

• Primary Sponsor: Suzuki Hiroaki
• Secondary ID(s): UMIN000030055