Middle ear implantation surgery

Middle ear implantation surgery - Middle ear implantation surgery

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005153

Enrollment

Registered

2011-04-01

Start date

2011-04-01

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 and mixed hearing loss

Interventions

The middle ear implant is performed under general anesthesia. The antromastoidectomy is performed, followed by an atticotomy and posterior tympanotomy and the floating mass transducer (oscillator) is

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult conductive hearing loss and mixed hearing loss with exteranal or middle ear disease patients. 1) Remaining hearing loss despite of the tympanoplasty or stapes surgery has done, and listening the conversation is insufficiency by air conductive HA. Or inflammation of middle ear and external canal get worth due to using HA. 2) External ear malfomation with conductive hearing loss and mixed hearing loss, who cannot use conventional hearing aids or who are unsatisfied with them and do not achieve sufficient benefit. Corresponding to the bone conduction hearing frequencies listed as follows 1) 500Hz is under 45dB 2) 1000Hz is under 50dB 3) 2000Hz and 4000Hz are under 65dB

Exclusion criteria

Exclusion criteria: The exclusion criteria are as follows: (1) Retrolabyrinthine deafness, central deafness (2) Active stage of refractory otitis media (3) Acute progressive sensorineural hearing loss (4) Inner ear disorder becaouse of labyrinthitis in adulthood (5) Chronic or refractory vestibular disfunction

Design outcomes

Primary

Measure	Time frame
The therapeutic effects are evaluated at 5 month after the middle ear implantation surgery, using the free field speech recognition threshold test. In the speech recognition threshold test with quiet, marked recovery is defined as any recovery of the maximum speech recognition score (%) by speech recognition threshold test using 67S or 57S Japanese monosyyrable word table (Japan Audiological Society 1967, 1957).	—

Measure

Time frame

The therapeutic effects are evaluated at 5 month after the middle ear implantation surgery, using the free field speech recognition threshold test. In the speech recognition threshold test with quiet, marked recovery is defined as any recovery of the maximum speech recognition score (%) by speech recognition threshold test using 67S or 57S Japanese monosyyrable word table (Japan Audiological Society 1967, 1957).

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Countries

Japan

Contacts

Public ContactSatoshi Iwasaki

Shinshu University school of Medicine Department of Otorhinolaryngology

Outcome results

None listed

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