Advanced Bionics HiResolution Bionic Ear System Instructions For Use Manual page 4

EN
Headpieces
Software
Sound Processors
INFORMATION FOR USE AND REQUIRED TRAINING: A Surgeon's Manual
and a video describing the surgical procedure and insertion of the electrode
are provided to all physicians prior to implantation. Physicians must be well
versed in mastoid surgery and the facial recess approach to the round window.
Advanced Bionics conducts periodic training courses on the recommended
surgical procedure to implant the HiRes Ultra 3D cochlear implant and strongly
recommends that surgeons who implant adults receive training.
All physicians implanting the HiRes Ultra 3D cochlear implant in children
must be trained in the implantation procedure. Failure to obtain the
appropriate training will result in a higher incidence of surgical and medical
complications.
Surgeons should work with an audiology professional who has been trained
fully on the proper fitting and adjustment of the system.
Device and Fitting Manuals are provided to all clinical centers with the
Clinician's Programming System. Audiologists must be highly skilled in
administering test procedures used to determine cochlear implant candidacy.
They should be knowledgeable about state-of-the-art hearing aid technology
and fitting procedures. In addition, at least one audiologist from a clinical
center should be fully trained and qualified in the fitting of the Advanced
Bionics cochlear implant in both adults and children. Advanced Bionics
conducts periodic training courses for audiologists and strongly recommends
that audiologists attend a training course. Failure to obtain the appropriate
training will result in less-than-optimal patient performance.
Instructions for use for external components of the HiResolution Bionics Ear
System are provided to the recipient upon delivery of the components. Patient
counseling materials are made available to all implant centers upon request.
These materials provide detailed information about the system, indications
for use, benefits, risks, and what is involved in patient selection, surgery, and
follow-up procedures.
CAUTION: Federal law restricts this device to sale, distribution and use by or
on the order of a physician. For use in children, federal law restricts this device
to sale, distribution and use by or on the order of a physician who is trained in
the pediatric implantation procedures for the HiResolution Bionic Ear System.
4
UHP 3D
AquaMic™ 3D
SoundWave 3.1 or later
Naída CI
Neptune
Harmony
Platinum Sound Processor (PSP)
REF
CI-1601-04 HiRes™ Ultra 3D CI HiFocus™ MS Electrode
CI-1601-05 HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode
CI-4509 HiRes™ Ultra Reusable Surgical Tool Kit
CI-4331 HiRes™ Ultra Recess Gauge
CI-4341 HiRes™ Ultra Coil Gauge
CI-4421 HiRes™ Ultra BTE Template
CI-4426 HiRes™ Ultra Mock Up
CI-4508 HiFocus™ Mid-Scala Electrode Instrument Kit
CI-4254 HiFocus™ Mid-Scala Claw Tool
CI-4347 HiFocus™ Mid-Scala Cochleostomy Gauge
CI-4507 HiFocus™ MS Electrode Insertion Tool Kit
CI-4207 HiFocus™ MS Electrode Insertion Tool
CI-1605 HiFocus™ SlimJ Electrode Depth Gauge
CI-4350-02 HiFocus™ Electrode Forceps Kit
029-M767-49 Rev A 2018-10-15