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32 | Additional guidance
Intended Patient Population: Air conduction hearing aids are intended for people (18 years
of age or older) who have been diagnosed by a licensed clinician or audiologist to have hearing
loss. The Multiflex Tinnitus Technology is targeted for patients suffering from tinnitus being
treated by healthcare professionals. The fitting of the Multiflex Tinnitus Technology should be
done by a hearing professional when participating in a Tinnitus Management Program.
Intended User and User Environment: Lay persons in a home and public environment.
Clinical Benefit: Clinical benefits include: (a) compensation for hearing loss, (b) relief from
Tinnitus symptoms (where applicable).
Clinical 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.
Safety Information
•
Please consult with your primary physician if you use other medical devices, such as
defibrillators or pacemakers prior to using hearing aids to ensure there is no risk of
disturbance or interference with existing devices.
•
Minor irritation and/or inflammation may occur as your ear becomes accustomed to having
an object in it; if so, please contact your hearing professional.
•
If an actual allergic reaction occurs, alternative earmold materials are available; contact
your hearing professional.
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Severe swelling, discharge from the ear, excessive wax or other unusual conditions warrant
immediate consultation with a physician.
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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.
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DO NOT OPEN HEARING AID OR CHARGER, NO USER-SERVICEABLE PARTS INSIDE.
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If the case or shell of your rechargeable device is broken, the rechargeable batteries may
be exposed. In this case, do not attempt to use the device, contact your hearing care
professional.
•
Chargers have a rating of IP 22 or IP 21 per IEC 60529, depending on what type of charger
you have. This means the unit is protected against solid objects over 12 mm, such as fingers
and falling water drops, such as condensation for IP21 and Protected against vertically
falling water drops when enclosure tilted up to 15° (for IP22).
•
Do not connect chargers to any devices not described in this IFU.
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The service life of the Starkey Charger is 3 years.
•
Keep the devices dry.
•
The user must not touch both hearing aid charging ports simultaneously.
EU Adverse Event Reporting: Any serious incident that has occurred in relation to your
Starkey device should be reported to your local Starkey representative and the Competent
Authority of the Member State in which you are established. A serious incident is defined as
any malfunction, deterioration in the characteristics and/or performance of the device, or
inadequacy in the device Operations Manual/ labeling which could lead to the death or serious
deterioration in the state of health of the user OR could do so upon recurrence.
Contraindications
•
Hearing aids are contraindicated for use during a Magnetic resonance imaging (MRI)
procedure or in a hyperbaric chamber.
•
Patients with the following conditions are advised to consult with a physician before using
hearing aids: visible congenital or traumatic deformity of the ear, history of active drainage
from the ear within the previous 90 days, history of sudden or rapidly progressive hearing
loss within the previous 90 days, acute or chronic dizziness, unilateral hearing loss of
sudden or recent onset within the previous 90 days, audiometric air-bone gap equal to or
greater than 15 decibels at 500 Hz, 1000 Hz, and 2000 Hz, visible evidence of significant
cerumen accumulation of a foreign body in the ear canal, pain or discomfort in the ear.
•
There are no contraindications for accessories to hearing aids (Fitting Software, Mobile
Software Applications, or accessories, e.g., (Mini) Remote Microphone+, Remote Control
(2.0), Charger.
Limitations: Not for use in patients younger than 18 years.
FCC Notice: This device complies with part 15 of the FCC rules and wireless hearing aids
also comply with ISED Canada's license-exempt RSS standard(s). Operation is subject to
the following two conditions: (1) This device may not cause harmful interference, and (2) this
device must accept any interference received, including interference that may cause undesired
operation of the device.*
NOTE:
The manufacturer is not responsible for any radio or TV interference caused by
unauthorized modifications to this equipment. Such modifications could void the user's
authority to operate the equipment.
Performance Data & Wireless Information
Specific hearing aid performance data and wireless information can be found on
https://eifu.starkey.com/eifu/ in data sheets.
Storage and Transportation
Use on Aircrafts: The optional wireless capabilities that may be featured in hearing aids can
be used on an aircraft as hearing aids are exempt from the rules applied to other personal
electronic instruments on an aircraft.
International Use: Wireless Hearing aids are approved to operate at a radio frequency that
is specific to your country or region and might not be approved for use outside your country
or region. Be aware that operation during international travel may cause interference to other
electronic hearing instruments, or other electronic instruments may cause interference to your
hearing aids.
Additional guidance | 33
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