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Additional guidance 35
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Additional guidance
INTENDED USE:
An air conduction hearing aid is a wearable sound-amplifying device
intended to compensate for impaired hearing. Hearing aids are
available in multiple gain/output levels appropriate to treat hearing
losses ranging from mild to profound.
Your hearing aids are designed to operate in public and residential
environments and are designed to comply with international
Electromagnetic Compatibility emissions and immunity standards for
medical devices. However, it is still possible that you may experience
interference caused by power line disturbances, airport metal
detectors, electromagnetic fields from other medical devices, radio
signals and electrostatic discharges.
If you use other medical devices or wear implantable medical devices
such as defibrillators or pacemakers and are concerned that your
hearing aids might cause interference with your medical device,
please contact your physician or the manufacturer of your medical
device for information about the risk of disturbance.
Your hearing aids should not be worn during an MRI procedure or
in a hyperbaric chamber or other oxygen-rich environments.
Your hearing aids are classified as a Type B applied part under the
IEC 60601-1 medical device standard.
Your hearing aids are not formally certified to operate in explosive
atmospheres such as may be found in coal mines or certain chemical
factories.
10% rH
95% rH
-10 C
45 C
Your hearing aids should be stored and
transported within the temperature, humidity,
and pressure ranges of -10°C (14°F) to +45°C
(113°F),10%-95% rH, and 70 kPa – 106 kPa
(equivalent to altitudes from 1,200 ft (380 m)
below sea level to 10,000 ft (3,000 m).
The charging temperature range is between 10°C (50°F) and 40°C
(104°F) and between 10%-95% RH and 70 kPa-106 kPa.
Your hearing aids are designed to operate beyond the range of
temperatures comfortable to you, from 0°C (32°F) up to 40°C (104°F).
CAUTIONS:
• If the product is hot, do not touch it until cool.
• If the product is not working, do not disassemble. Due to a shock
hazard, please send in for repair.
• Keep out of reach from children. Do not ingest anything in the
package, including desiccant, cleaning tool, etc.
• Any cords and AC adapters must be approved or listed by a
Nationally Recognized Testing Laboratory.
Clinical benefit
The hearing aid is designed to provide better speech understanding to
help ease communication with the aim of improving quality of life.
Intended use
Clinical Study Summary
A clinical study, including adults aged 18 years and over with
hearing losses ranging from mild to profound, assessed hearing aid
performance and benefit. Over the course of 2-6 weeks of device
wear, users completed various laboratory and field assessments to
determine if the devices met clinical expectations. The results of the
study confirm that the devices provide amplification appropriate
for the users’ hearing losses, and that users perceive benefit from
amplification consistent with normative data. There were no serious
or lasting adverse events encountered during the study.
Use on Aircrafts
The wireless capabilities that may be featured in your Hearing
Instruments can be used on an aircraft as Hearing Instruments
are exempt from the rules applied to other personal electronics
instruments on an aircraft.
DO NOT OPEN HEARING AID, NO USER-
SERVICEABLE PARTS INSIDE
Required Multiflex Tinnitus Information for Hearing
Care Professionals
INDICATIONS FOR USE
The Multiflex Tinnitus Technology is a tool to generate sounds to be
used in a Tinnitus Management Program to relieve patients suffering
from tinnitus. The target population is primarily the adult population
over 18 years of age.
The Multiflex Tinnitus Technology is targeted for healthcare
professionals, which are treating patients suffering from tinnitus, as
well as conventional hearing disorders .The fitting of the Multiflex
Tinnitus Technology must be done by a hearing care professional
participating in a Tinnitus Management Program.
INSTRUMENT DESCRIPTION
Multiflex Tinnitus Technology is a software function that generates
sound which is programmed into a hearing aid. The hearing aid
may be used in one of three modes of operation: as a hearing aid,
as a tinnitus treatment instrument or as a hearing aid and tinnitus
treatment instrument.
When enabled, the Multiflex Tinnitus Technology generates the sound
and allows a patient’s hearing care professional to design and program
appropriate settings for an individually prescribed sound treatment
plan. The treatment plan should be used in a tinnitus management
program for relief of tinnitus.
Multiflex Tinnitus Technology generates a broadband white noise
signal that varies in frequency and amplitude. These characteristics
are adjustable by the hearing care professional and are specific to
the prescribed therapy designed by the professional for the patient’s
needs and comfort.
The patient may have some control of the level or volume of the
signal and the patient should discuss this adjustment as well as his
or her comfort level and sound of the signal with their hearing care
professional.
Intended use
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