Patient Counseling Information - Advanced Bionics HiResolution Bionic Ear System Instructions For Use Manual

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Table 1
Mean Speech Scores for HiRes and HiRes 120
Sound Processing Group HiRes
Test Interval Baseline
CNC Words 63
HINT Sentences in Quiet 88
Hint Sentences in Noise
64
(+8 dB SNR)
* HiRes 120 score significantly different from baseline HiRes score (p<.05)
** HiRes 120 score significantly different from baseline and 3-month HiRes
scores (p<.05)
Forty-three of 50 subjects (86%) preferred HiRes 120 over HiRes. Subjects
rated strength of preference for the two strategies on a scale from 1 (weak
preference) to 10 (strong preference). The mean strength of preference for
the 43 subjects who preferred HiRes 120 was 7.9 (range: 1-10). The strength
of preference was rated as 8 or higher by 26 of the 43 subjects, and 16 of the
43 subjects rated their preference as 10 (strong preference). For the 7 subjects
who preferred HiRes, the mean strength of preference was 4.4 (range: 1-9).
ClearVoice
A clinical study was conducted in 46 adults who had at least six months
experience with HiRes 120 sound processing and at least moderate speech
perception abilities to investigate the benefits of ClearVoice. ClearVoice has
three adaptive gain settings that allow individuals to select the setting that
provides the best hearing—Low, Medium, and High. A two-week randomized,
crossover design was used to evaluate ClearVoice-Medium and ClearVoice-
High. ClearVoice-Low was evaluated acutely during an initial test session.
Speech benefit was compared for ClearVoice vs. HiRes 120 without ClearVoice
(Control) using the AzBio sentence test.
Speech understanding in speech-spectrum noise was significantly better with
ClearVoice- Medium and ClearVoice-High compared to the Control (p < .0001).
ClearVoice-Medium significantly improved speech understanding in multi-talker
babble (p< .02). Speech understanding was no worse than the Control when
listening in quiet for both ClearVoice Medium and ClearVoice High (p < .0001).
Speech understanding with ClearVoice-Low was no worse than the Control in
quiet, in speech-spectrum noise, and in multi-talker babble (p <.001).
Table 2
Mean AzBio Sentence Scores for HiRes 120 with and without ClearVoice
Study Group Control ClearVoice
Low
Quiet 87.3 87.8
Speech-Spectrum 48.0 55.6
Noise
Multi-Talker 42.8 47.2
Babble
Preference ratings indicated that 42 out of 45 subjects (93%) preferred
ClearVoice to the Control for everyday listening (one subject did not complete
the questionnaire). The mean strength of preference for the 42 subjects who
preferred ClearVoice was 7.9 (1 = weak preference, 10 = strong preference).
Of the 42 subjects preferring ClearVoice, 22 indicated they would use it all
of the time, 17 indicated they would use it most of the time, and 3 indicated
they would use it some of the time. Of the 3 subjects preferring the Control, all
indicated they would use ClearVoice some of the time.
ClearVoice is not approved for pediatric use in the United States.
ClearVoice is only available in markets where ClearVoice has received regulatory
approval. Contact Advanced Bionics for more information.
For additional information about the clinical studies and clinical results including
safety and efficacy, please contact your AB representative.
POSSIBLE ADVERSE EVENTS: The following risks associated with cochlear
implantation and ear surgery also can occur.
HiRes 120 HiRes
3 Months 3 Months
65 63
93* 91
70** 65
Control ClearVoice Control ClearVoice
Medium High
88.6 88.3 86.8 87.7
49.5 58.2 47.7 58.3
44.9 48.1 44.9 46.2
• Implant recipients incur the normal risks of surgery and general anesthesia.
• Major ear surgery may result in numbness, swelling or discomfort about the
ear, disturbance of taste or balance, or neck pain. If these events occur, they are
usually temporary and subside within a few weeks of surgery.
• Rarely, cochlear implantation may cause a leak of the inner ear fluid, which
may result in meningitis.
• During the surgery, it is a rare possibility that the facial nerve could be injured
resulting in a temporary or permanent weakening or full paralysis on the
same side of the face as the implant.
• During the surgery, there is a rare possibility that cerebrospinal fluid leakage or
perilymph fluid leakage could occur.
• As a result of the surgery, it is possible that dizziness, tinnitus, or vertigo may
result. If these events occur, they are usually temporary and subside over time.
• The presence of a foreign body may cause irritation, inflammation, or skin
breakdown and may require additional medical treatment or removal of the
internal device.
• Skin infection in the area of the implant may require additional medical
treatment or removal of the internal device.
• There is a possibility that the electrode or device may migrate requiring
additional medical treatment or removal of the internal device to address
any resulting injury.

PATIENT COUNSELING INFORMATION

Prospective cochlear implant candidates must be counseled appropriately on
expected outcomes prior to surgery. Patients demonstrate a range of cochlear
implant benefit.
Although it is not possible to predict post-implant performance preoperatively
for individual patients, research and clinical experience have shown that age
at implant, duration of severe-to-profound hearing loss, and preoperative
speech perception skills have a significant effect on post-implant performance.
Ear selection for implantation is left to the discretion of the patient, surgeon,
and audiologist. There is no consensus in the field regarding implantation of
the better versus poorer ear. If the poorer ear is implanted, patients should
be counseled that postoperative performance ear may not equal that of the
better non-implanted ear, especially if there also is long duration of deafness
and negligible residual hearing preoperatively.
Communication mode (oral versus total communication) and the patient's
auditory environment can affect outcomes in children. Implant-center
professionals should counsel parents about the impact of communication
mode and auditory environment on potential implant benefit in the pediatric
population.
TELEMETRY: The HiResolution Bionic Ear System incorporates bi-directional
telemetry that verifies system function and continuously monitors the system
during normal use.
STORAGE: The HiResolution Bionic Ear System should be stored at
temperatures in the range of 0° to 50° Centigrade (32° to 122° Fahrenheit).
HANDLING: The HiRes Ultra 3D cochlear implant package should be
handled with care. An impact that damages the storage pack also could
rupture the sterile packaging.
SHELF LIFE: A Use Before date is stamped on the packaging and is based
on the date of the original sterilization.
STERILIZATION: The HiRes Ultra 3D cochlear implant is supplied in ethylene
oxide sterile packaging with indicators of sterilization. Sterile packs should
be inspected carefully to confirm that they have not been ruptured. Sterility
cannot be guaranteed if the sterile package is damaged or opened. If the
sterile pack of the HiRes Ultra 3D cochlear implant is damaged, the device
must not be used. If the sterile packaging of the HiRes Ultra 3D cochlear
implant has been opened, the cochlear implant cannot be resterilized
by either the customer or Advanced Bionics.
PRESSURIZED ENVIRONMENT INFORMATION: The HiRes Ultra 3D cochlear
implant can withstand a pressure up to a depth of 42m under water (138 feet)
or a gauge pressure of 4ATM (413 kPa).
COMPATIBILITY: The HiRes Ultra 3D cochlear implant is compatible with the
following external system components and their corresponding accessories:
3