Electric and acoustic stimulation (EAS) type cochlea implantation surgery (2)

Electric and acoustic stimulation (EAS) type cochlea implantation surgery (2) - EAS type cochlea implantation (2)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005894

Enrollment

Registered

2011-06-30

Start date

2011-03-01

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

Bilateral profound sensorineural hearing loss

Interventions

The EAS choclea implantation is performed under general anesthesia. Same as standard cochlea implant surgeries, an antromastoidectomy is performed, followed by an atticotomy and posterior tympanotomy

Skarzynski et al.,2007). This electrode insertion technique is able to preserve residual hearing in low frequencies.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult bilateral profound sensorineural hearing loss patient with a ski-slope type hearing loss corresponding to the frequencies listed here: 1) 125Hz, 250Hz, and 500Hz are under 65dB. 2) 2000Hz is over 80dB. 3) 4000Hz and 8000Hz are over 85dB. One of the above mentioned frequencies may be out of the mentioned decibel lebels by 10dB still be considered as a subject. The maximum speech recognition score in quiet of EAS subject should be under 60% at 65dB in the best aided condition wearing the hearing aid.

Exclusion criteria

Exclusion criteria: The exclusion criteria are as follows: (1)Acute progressive hearing loss (2)autoimmune disease (3)Hearing loss casused by meningitis, otosclerosis and ossification (4)Malformations or obstruction of the cochlea (5)Conductive hearing loss (6)External ear cojtra indications to using amplification devices

Design outcomes

Primary

Measure	Time frame
The therapeutic effects are evaluated at 6 month and 12 month after the EAS operation, using the free field audiometry and speech recognition threshold test. In the free field audiometry test, marked recovery is defined as more than 30 dBSPL recovery in the mean hearing level at the 2000Hz, 4000Hz and 8000Hz. In the speech recognition threshold test, marked recovery is defined as any recovery of the maximum speech recognition score (%) by speech recognition threshold test using 67S or 57S Japanese monosirable word tabele (Japan Audiological Society 1967, 1957).	—

Measure

Time frame

The therapeutic effects are evaluated at 6 month and 12 month after the EAS operation, using the free field audiometry and speech recognition threshold test. In the free field audiometry test, marked recovery is defined as more than 30 dBSPL recovery in the mean hearing level at the 2000Hz, 4000Hz and 8000Hz. In the speech recognition threshold test, marked recovery is defined as any recovery of the maximum speech recognition score (%) by speech recognition threshold test using 67S or 57S Japanese monosirable word tabele (Japan Audiological Society 1967, 1957).

—

Secondary

Measure	Time frame
The secondary outcome are evaluated at 3 month and 6 month after the EAS operation, using pure tone audiometry. In this test, marked effective is defined as less than 40 dBSPL deterioration in the mean hearing level at the 125Hz, 250Hz and 500Hz.	—

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