Cochlear Nucleus 5 System

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Beschikbaar vanaf:

COCHLEAR LIMITED

klasse:

Class D medical device

Geproduceerd door:

Cochlear Limited

Therapeutisch gebied:

Ear, Nose & Throat

therapeutische indicaties:

To provide auditory sensation and sound perception by electrically stimulating the auditory nerve. Indications: a. Individuals aged 12mth to 17yrs with clinically established bilateral or unilateral sensorineural hearing loss and who have compromised functional hearing or would receive no benefit with hearing aids. Typical preoperative threshold levels in the impaired ears demonstrate a pure-tone average loss of moderately severe to profound degree. b. Individuals aged 18yrs and older with clinically established postlinguistic bilateral or unilateral sensorineural hearing loss and who have compromised functional hearing or would receive no benefit with hearing aids. Typical preoperative threshold levels in the impaired ears demonstrate a pure-tone average loss of moderately severe to profound degree. c. Prelinguistically or perilinguistically deafened individuals aged 18yrs and older who have profound bilateral sensorineural hearing loss and compromised hearing with hearing aids.

Product samenvatting:

Device System Info:[System or Procedure Pack], [Sterile Medical Device], Consisted of the cochlear implant, sound processor, remote assistant and custom sound suite software. Ethylene oxide sterilised.; Models: Nucleus CP810 Sound Processor - CP810, Nucleus CI512 Cochlear Implant - CI512, Sterile Silicone Implant Template - S211296, Nucleus® CI500 Series Surgical Instrument Upgrade Kit - Z145225, Replacement magnet - Z179608, Titanium plug - Z146624, Nucleus System 3 Surgical kit - Z60523

Autorisatie datum:

2010-07-01