Starkey RIC 312 Wireless Hearing Aid User Manual
- July 31, 2024
- Starkey
Table of Contents
RIC 312 Wireless Hearing Aid
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Product Specifications
- Product Name: Wireless Hearing Aid
- Model: RIC (Receiver-In-Canal) 312
- Product Code: P00002032
Product Usage Instructions
Warnings and Precautions
It is important to follow these warnings and precautions for
safe and effective use of your wireless hearing aid:
-
People under 18 should consult a doctor before using the
hearing aid to avoid potential worsening of impairment. -
Hearing aid dispensers should advise users with specific
conditions to consult a doctor before dispensing the device. -
Avoid using the hearing aid directly next to other electronic
equipment to prevent improper performance. -
Use only accessories, components, or replacement parts provided
by the manufacturer to maintain performance and safety
standards. -
Avoid placing portable radio frequency communications equipment
closer than 30 cm from the hearing aid to prevent performance
degradation. -
Avoid physical impacts to the ear when wearing the hearing aid
to prevent damage. -
If the hearing aid drops onto a hard surface or is damaged,
discontinue use and seek professional evaluation.
International Use
Your hearing aids are approved for use in specific radio
frequencies in your country or region. Avoid using them outside
approved regions to prevent interference with other electronic
devices.
Frequently Asked Questions (FAQ)
Q: Can I use the wireless hearing aid without consulting a
doctor?
A: It is recommended that individuals under 18 years old consult
a doctor, preferably an ear specialist, before using the hearing
aid to ensure proper evaluation and care.
Q: What should I do if my hearing aid drops and gets
damaged?
A: If your hearing aid drops onto a hard surface or becomes
damaged, discontinue use immediately and seek evaluation from a
hearing professional.
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Your Wireless Hearing Aid User Manual
Wireless Products RIC (Receiver-In-Canal) 312
P00002032
2 | Warnings, Cautions, & Notices
REQUIRED HEARING AID INFORMATION The following additional information is
provided in compliance with U.S. Food and Drug Administration (FDA)
regulations:
WARNING: People younger than 18 should go to a doctor before using this.
People younger than 18 years old need specialized care, and using this without
a medical evaluation may worsen impairment or disability. A hearing aid user
who is younger than 18 should have a recent medical evaluation from a doctor,
preferably an ear-nose-throat doctor (an ENT). Before using this, a doctor
should determine that the use of a hearing aid is appropriate.
WARNING: to Hearing Aid Dispensers:
You should advise a prospective hearing aid user to consult promptly with a
doctor, preferably an ear specialist such as an ENT, before dispensing a
hearing aid if you determine through inquiry, actual observation, or review of
any other available information concerning the prospective user, that the
prospective user has any of the following conditions:
· Visible deformity of the ear, either congenital or traumatic · Fluid, pus,
or blood coming out of the ear within the previous 6 months · Pain or
discomfort in the ear · History of excessive ear wax or suspicion that
something is in the ear canal · Dizziness, either recent or long-standing ·
Sudden, quickly worsening, or fluctuating hearing loss within the previous 6
months · Hearing loss or ringing (tinnitus) only in one ear or a noticeable
difference in hearing between ears · Audiometric air-bone gap equal to or
greater than 15 dB at 500 Hz, 1000 Hz, and 2000 Hz
WARNING: to Hearing Aid Dispenser, Outputs
over 132 dB SPL: You should exercise special care in selecting and fitting a
hearing aid with a maximum output that exceeds 132 dB SPL because it may
impair the remaining hearing of the hearing aid user.
International Use Your 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 instruments,
or other electronic instruments may cause interference to your hearing aids.
We are required by regulations to provide the following warnings:
WARNING: Use of wireless hearing aids directly next to other electronic
equipment should
be avoided because it could result in improper performance. If such use is
necessary, note as to whether your hearing aids and the other equipment are
operating normally.
WARNING: Use of accessories, components or replacement parts other than those
provided
by the manufacturer of your hearing aids could result in increased
electromagnetic emissions and decreased electromagnetic immunity and could
result in degradation of performance.
Warnings, Cautions, & Notices | 3
WARNING: If Portable Radio Frequency communications equipment is used closer
than
30 cm (12 inches) from your hearing aid, degradation of the performance of
your hearing aid could result. If this occurs, move away from the
communications equipment.
WARNING: The stability of the hearing aid is designed for normal use. Avoid
physical
impacts to the ear when wearing a hearing aid that may cause the device to
break or component of the device to become detached. This may lead to
lacerations of the ear canal or perforation of the ear drum. If this occurs,
it is strongly recommended to see a physician for evaluation and safe removal.
WARNING: If the hearing aid drops onto a hard surface, it could cause the
hearing aid to
break or become damaged. This includes mechanical stress or shock of the
device. Ensure the hearing aid is intact before placing it in the ear. If you
find the device is damaged, discontinue use and see your hearing professional.
WARNING: Repeated stress to the removal handle may cause it to break. If the
removal
handle breaks and you’re unable to remove the device carefully, it is
recommended to see a physician for safe removal.
WARNING TO HEARING CARE PROFESSIONAL
A hearing care professional should advise a prospective sound generator
(tinnitus masker) user to consult promptly with a licensed physician
(preferably an ear specialist) before using a sound generator if the hearing
care professional determines through inquiry, actual observation or review or
any other available information concerning the prospective user that the
prospective user has any of the following conditions:
· 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
WARNING: There are some potential concerns associated with the use of any
sound
generating tinnitus therapy instrument. Among them are the potential for
worsening of tinnitus, a possible change in hearing thresholds, and possible
skin irritation at the point of contact with the hearing aid.
Multiflex Tinnitus Technology has been designed to minimize these concerns.
However, should you experience or notice any of the above conditions or any
dizziness, nausea, headaches or heart palpitations, you should immediately
discontinue use of the hearing aid and seek a consultation with a medical,
audiology or other hearing care professional.
As with any hearing aid, misuse of the tinnitus therapy instrument could
present some potentially harmful effects. Care should be taken to prevent the
unauthorized use and to keep the hearing aid out of the reach of children and
pets.
4 | Warnings, Cautions, & Notices
FALL ALERT FEATURE The Fall Alert feature can be used to notify others should
you fall or experience a non-fall-related event. This feature can be
configured to send an SMS text message to predefined contacts. Fall Alert can
be configured to send automated and/or manually-initiated alerts.
WARNING: Auto Alert may not detect 100 percent of falls
WARNING: Decreasing the Auto Alert Sensitivity may prevent some falls from
being
detected by your Fall Alert system. For example, Auto Alert may not detect a
fall if: · The Sensitivity setting is not appropriate for the user · The fall
is very slow, or you slide down gradually · You get up and begin walking
immediately after a fall
WARNING: Auto Alert may initiate false alerts. To prevent false-alert text
messages from
being sent to your contact(s), you may cancel the alert from either your
smartphone or by pressing the user control on either hearing aid.
WARNING: To reduce Fall Alert communication failures:
· Your hearing aid(s) need to be powered on, paired and connected with your
smartphone using Bluetooth® connectivity
· The mobile device must be powered on, with the hearing aid mobile app open
(in the foreground or background)
· The mobile device must have a connection to the Internet (via a cellular
network or WiFi)
CAUTION: This is not hearing protection.
You should remove this device if you experience overly loud sounds, whether
short or long-lasting. If you’re in a loud place, you should use the right
kind of hearing protection instead of wearing this device. In general, if you
would use ear plugs in a loud place, you should remove this device and use ear
plugs.
CAUTION: The sound output should not be uncomfortable or painful.
You should turn down the volume or remove the device if the sound output is
uncomfortably loud or painful. If you consistently need to turn the volume
down, you may need to further adjust your device.
CAUTION: You might need medical help if a piece gets stuck in your ear.
If any part of your hearing aid, like the eartip, gets stuck in your ear, and
you can’t easily remove it with your fingers, get medical help as soon as you
can. You should not try to use tweezers or cotton swabs because they can push
the part farther into your ear, injuring your eardrum or ear canal, possibly
seriously. NOTE: What you might expect when you start using a hearing aid. A
hearing aid can benefit many people with hearing loss. However, you should
know it will not restore normal hearing, and you may still have some
difficulty hearing over noise. Further, a hearing aid will not
Warnings, Cautions, & Notices | 5
prevent or improve a medical condition that causes hearing loss.
People who start using hearing aids sometimes need a few weeks to get used to
them. Similarly, many people find that training or counseling can help them
get more out of their devices.
If you have hearing loss in both ears, you might get more out of using hearing
aids in both, especially in situations that make you tired from listening–for
example, noisy environments.
NOTE: Tell FDA about injuries, malfunctions, or other adverse events.
To report a problem involving your hearing aid, you should submit information
to FDA as soon as possible after the problem. FDA calls them “adverse events,”
and they might include: skin irritation in your ear, injury from the device
(like cuts or scratches, or burns from an overheated battery), pieces of the
device getting stuck in your ear, suddenly worsening hearing loss from using
the devices, etc.
Instructions for reporting are available at
https://www.fda.gov/Safety/MedWatch, or call 1-800-FDA-1088. You can also
download a form to mail to FDA.
NOTE: Hearing loss in people younger than 18.
· People younger than 18 should see a doctor first, preferably an ear-nose-
throat doctor (an ENT), because they may have different needs than adults
· The doctor will identify and treat medical conditions as appropriate · The
doctor may refer the person to an audiologist for a separate test, a hearing
aid evaluation · The hearing aid evaluation will help the audiologist select
and fit the appropriate hearing aid
A person who is younger than 18 years old with hearing loss should have a
medical evaluation by a doctor, preferably an ENT, before buying a hearing
aid. The purpose of a medical evaluation is to identify and treat medical
conditions that may affect hearing but that a hearing aid won’t treat on its
own.
Following the medical evaluation and if appropriate, the doctor will provide a
written statement that the hearing loss has been medically evaluated and the
person is a candidate for a hearing aid. The doctor may refer the person to an
audiologist for a hearing aid evaluation, which is different from the medical
evaluation and is intended to identify the appropriate hearing aid.
The audiologist will conduct a hearing aid evaluation to assess the person’s
ability to hear with and without a hearing aid. This will enable the
audiologist to select and fit a hearing aid for the person’s individual needs.
An audiologist can also provide evaluation and rehabilitation since, for
people younger than 18, hearing loss may cause problems in language
development and educational and social growth. An audiologist is qualified by
training and experience to assist in the evaluation and rehabilitation of
hearing loss in people younger than 18.
IMPORTANT NOTICE FOR PROSPECTIVE Rx HEARING AID USERS:
It is good health practice for a person with a hearing loss to have a medical
evaluation by a licensed physician (preferably a physician who specializes in
diseases of the ear) before purchasing a prescription hearing aid. Licensed
physicians who specialize in diseases of the ear are often referred to as
otolaryngologists, otologists or otorhinolaryngologists. The purpose of the
medical evaluation is to assure that all medically treatable conditions that
may affect hearing are identified and treated before the hearing aid is
purchased.
Following the medical evaluation, the physician will give you a written
statement that states that your hearing loss has been medically evaluated and
that you may be considered a candidate for a hearing aid. The physician will
refer you to an audiologist or hearing aid dispenser, as appropriate, for a
hearing aid evaluation.
6 | Warnings, Cautions, & Notices
| 7
The audiologist or hearing aid dispenser will conduct a hearing aid evaluation
to assess your ability to hear with and without a hearing aid. The hearing aid
evaluation will enable the audiologist or dispenser to select and fit a
hearing aid to your individual needs.
If you have reservations about your ability to adapt to amplification, you
should inquire about the availability of a trial-rental or purchase option
program. Many hearing aid dispensers now offer programs that permit you to
wear a hearing aid for a period of time for a nominal fee after which you may
decide if you want to purchase the hearing aid.
In some geographies, you must have a medical evaluation before purchasing a
prescription hearing aid. Some states allow an adult to waive the medical
evaluation.
A hearing aid will not restore normal hearing and will not prevent or improve
a hearing impairment resulting from organic conditions. Use of a hearing aid
is only part of hearing habilitation and may need to be supplemented by
auditory training and instruction in lip reading. In most cases infrequent use
of a hearing aid does not permit a user to attain full benefit from it.
Some hearing instrument users have reported a buzzing sound in their hearing
instrument when they are using mobile phones, indicating that the mobile phone
and hearing instrument may not be compatible. It is well-known that mobile
phones are potential sources of noise for hearing aids. Your Starkey Hearing
Aids have been tested for compliance to two standards that define hearing aid
immunity to digital wireless devices and meet the requirements of ANSI C63.19-
2019 as well as the criteria for user compatibility as defined by IEC
60118-13:2019.
CAUTION: The following are potential physiological side effects from use of
hearing aids.
Consult a physician if the following occur:
· Worsening of hearing loss or tinnitus · Pain or discomfort from heat
(burns), abrasion (cuts and scratches), infection, shock · Dermal allergic
reaction (inflammation, irritation, swelling, discharge) · Excessive
production of cerumen (earwax)
8 | What’s included Congrats on your new hearing aids! Use this helpful manual
to get to know your new hearing aids and get the most out of your hearing
experience. After all, when you hear better, you live better. Thanks to your
new hearing aids. Hearing aids covered in this user manual (select yours):
RIC 312
Serial Number Left: Right:
My hearing aid uses a: 312 battery (RIC) Brown
Did you know you can get even more hearing aid features using your mobile
device? See your Setting Up Your Compatible Mobile App guide for details.
Table of contents
1. Warnings, cautions, & notices
2. Get to know your hearing aids Meet your hearing aids Use your hearing aids
Care for your hearing aids
3. Troubleshooting guide
4. Additional guidance Intended use FCC information Regulatory information
TOC | 9
2
10 12 20 25
28 31 32
10 | Get to know your hearing aids
Meet your hearing aids Overview 1. Cable 2. Microphones 3. User control:
Rocker switch 4. Receiver 5. Wax guard (included accessory) 6. Manufacturer,
model name, & serial number 7. Finger pick (located on battery door) 8. Side
indicator
RED is for right ear, BLUE is for left ear 9. Battery compartment (on/off
control) 10. Retention lock (optional) 11. Earbud (included accessory) 12.
Receiver indicator
RED is for right ear, BLUE is for left ear 13. Custom earmold (optional) 14.
Custom power earmold (optional)
Get to know your hearing aids | 11
RIC 312
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12 | Get to know your hearing aids
Use your hearing aids Batteries Your hearing aid uses a battery as its power
source. The battery size can be identified by the brown (312) color code on
the packaging. To insert or replace the battery: 1. Use the finger pick on the
battery door.
2. Open the battery door gently and remove the old battery.
3. Remove the colored tab from the new battery. For best results, wait 35
minutes after removing tab before inserting battery.
Get to know your hearing aids | 13 4. Insert into the battery door, “+” side
up.
5. Close the battery door.
Battery Indicators An indicator will sound when the battery voltage is low.
You have approximately 30 minutes to replace the battery. An indicator may
also sound just before the battery stops working. Helpful battery tips
· NEVER FORCE THE BATTERY DOOR SHUT; this could result in serious damage. If
the door will not close securely, check that the battery is inserted
correctly.
· Do not open the battery door too far or damage is likely to occur.
· Dispose of used batteries immediately in the proper waste or recycling
container.
14 | Get to know your hearing aids
WARNINGS Batteries are dangerous if swallowed. To help prevent the accidental
ingestion of batteries:
· Keep out of the reach of children and pets. · Check your medications before
taking them – batteries have
been mistaken for pills. · Never put batteries in your mouth, as they can
easily be
swallowed.
NATIONAL BATTERY INGESTION HOTLINE:
800-498-8666
To turn ON: Insert a battery and completely close the battery door. Your
hearing aid has a power-on delay which may require a few seconds. You may hear
a tone indicating that your hearing aid is powered on. To put on your hearing
aids: 1. Take your hearing aid. Slide the top of it behind your ear, so the
cable and earbud (or earmold) hang in front.
Get to know your hearing aids | 15 2. Ease the earbud or earmold into your ear
canal until secure.
(For earmolds, gently press into place with your fingertip.) The cable should
sit flat against your head. 3. Tuck the optional retention lock into the
bottom curve of your ear, so that the tip bends toward the back of your head.
Done!
To remove your hearing aids: 1. Gently pull the optional retention lock from
the bottom curve of
your ear then pull the earbud or earmold from your ear canal.
2. Lift your hearing aid out from behind your ear.
16 | Get to know your hearing aids
To turn OFF:
Open the battery door until the battery is no longer touching the battery
contacts. Auto ON/OFF
Your hearing aid may support the ability to automatically go into a low-
powered state to conserve battery. This control can be configured by your
hearing care professional or via the hearing aid mobile app.
Place your hearing aid on a flat, stable surface (e.g. a table) with your
earmold or earbud facing upwards and it will go into a low-powered state after
about 15 minutes. To resume normal hearing aid function, pick up your hearing
aid and place it in your ear. Your hearing aid will detect this motion and
switch back on again. You may hear a tone indicating that your hearing aid is
powered on.
Get to know your hearing aids | 17
Turning ON
Turning OFF
Battery door
Insert your battery and close the battery door securely.
A 3-second delay occurs before your hearing aid turns ON. This allows time to
place it in your ear.
Each hearing aid will turn OFF when you open the battery door (and the battery is no longer touching the battery contacts).
User control: Rocker switch
If you turned OFF each hearing aid by pressing the top or bottom button of the
rocker switch, pressing the top of the rocker switch will turn it ON.
A 3-second delay occurs before your hearing aid turns ON, allowing time to
place it in your ear.
Turn OFF each hearing aid by pressing and holding the top or bottom button of the rocker switch for 3 seconds.
18 | Get to know your hearing aids
User control Your hearing aid user control lets you control your hearing aids
by hand. This is set up by your hearing care professional, who can also
program the button to let you use many smart features. Your user control
operates in 3 ways:
· Short press: Press the user control for 1 second and then release.
· Long press: Press and hold the user control for 3 seconds or more.
· Tap Control: Firmly double-tap on or near your hearing aid.
User control
Short press (1 second) Long press (3 seconds)
Tap Control
Smart feature
Did you know you can also control your hearing aids using your mobile phone or other smart device? See your Setting Up Your Compatible Mobile App guide to learn more.
Get to know your hearing aids | 19
Phone calls and hearing aids Your hearing aids are designed to accommodate
calls on your mobile or landline phone.
· Landline calls To use your landline phone while wearinghearing aids, talk to
your hearing care professional. They can help you set up a “telephone” setting
on your hearing aids and offer tips.
· Mobile calls To stream mobile phone calls to your hearing aids, see the
Setting Up Your Compatible Mobile App guide included. This shows how to
connect (“pair”) your smartphone to your hearing aids.
Questions? Your hearing care professional can help.
Care for your hearing aids
Keep your hearing aid clean at all times. Heat, moisture and foreign
substances can result in poor performance. 1. Do not clean using water,
solvents, cleaning fluids, or oils.
Do not take your hearing aid apart or insert a cleaning tool inside of them.
2. Using the cleaning tool included inside your case, brush or wipe debris
from microphone, wax guard, and sound outlet.
20 | Get to know your hearing aids
3. Wipe hearing aids daily over a soft cloth to prevent damage should they
drop to a hard surface. If the hearing aid falls/drops onto a hard surface, it
could cause the shell or casing to break and/or become damaged. This includes
mechanical stress or shock of the device.
See your hearing care professional for more care and maintenance tips.
Replacing wax guards The wax guards prevent earwax from building up in your
hearing aids. It’s best to replace these if you notice built-up debris or poor
sound from your hearing aids.
To replace your wax guards: 1. Insert the empty end of the application stick
straight into the
used wax guard of your hearing aid. Push firmly.
Get to know your hearing aids | 21 2. Pull the application stick straight out
to remove the used wax
guard. Do not twist.
3. Use the opposite end of the application stick to insert the new wax guard
straight into the hearing aid. Push firmly.
4. Pull straight out to remove the application stick. Do not twist. Discard
the application stick. Done!
22 | Get to know your hearing aids Replacing earbuds It’s a good idea to
replace your earbud regularly or if your earbud is loose, misshaped, or
discolored from oils and moisture. A change in sound quality can also be a
signal to replace your earbuds. To replace your earbuds: 1. Pull the old
earbud from the receiver of your hearing aid.
2. Hold your hearing aid’s cable where it meets the receiver.
Get to know your hearing aids | 23 4. Push firmly to ensure the earbud
attaches securely to the receiver.
5. Ensure the earbud fully covers the threaded portion of the receiver. Done!
3. Place the end of the receiver into the middle of your new earbud.
24 | Troubleshooting guide
Troubleshooting guide
If, for any reason, your hearing aid does not operate properly, do NOT attempt
to fix it yourself. Not only are you likely to violate any applicable
warranties or insurance, you could easily cause further damage.
Should your hearing aid fail or perform poorly, check this troubleshooting
guide for possible solutions. If problems continue, contact your hearing care
professional for advice and assistance. Many common problems may be solved in
your hearing care professional’s office or clinic.
Symptom
Troubleshooting guide | 25
Possible causes
Solutions
Blocked earbud, earmold, or tubing.
1. Clean your hearing aids.
2. Replace the wax guards as needed.
Hearing aids are not loud enough.
Buildup of debris.
Change in your hearing.
Low battery.
Clean the microphone and receiver with your cleaning tool brush.
Contact your hearing care professional.
Replace battery.
Inconsistent hearing aid performance.
Blocked earbud, earmold, or tubing.
1. Clean your hearing aids.
2. Replace the wax guards as needed.
Low battery.
Replace battery.
26 | Troubleshooting guide
Symptom
Possible causes
Solutions
Blocked earbud, earmold, or tubing.
Unclear and distorted hearing aid performance.
Low battery.
1. Clean your hearing aids. 2. Replace the wax guards
as needed.
Replace battery.
Defective hearing aids.
Contact your hearing care professional.
Blocked earbud, earmold, or cable.
1. Clean your hearing aids.
2. Replace the wax guards as needed.
No sound coming from your hearing aids.
Low battery. Crimped cable.
Replace battery.
Contact your hearing care professional.
Receiver cable may not be fully connected to your hearing aid.
Disconnect and reconnect receiver cable to your hearing aid.
Additional guidance | 27
Intended Use
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 -40° C
45° C Your hearing aids should be stored and transported within the temperature, humidity, and pressure ranges of -10°C 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).
Your hearing aids are designed to operate beyond the range of temperatures comfortable to you, from 0° to 40°C.
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.
Clinical benefit
The hearing aid is designed to provide better speech understanding to help
ease communication with the aim of improving quality of life.
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.
28 | Additional guidance
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
aircraf t.
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 hearing care 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.
CAUTION: If set to the maximum output level and worn for periods of time
exceeding the
recommendations below, the patient’s exposure to sound energy has the
potential to exceed noise exposure limits. This hearing aid is intended for
use for a maximum of sixteen (16) hours a day when set at the maximum output
level.
For the Patient A tinnitus therapy instrument is an electronic instrument
intended to generate noise of sufficient intensity and bandwidth to treat
ringing in the ears. It can also be used as an aid in hearing external sounds
and speech.
Multiflex Tinnitus Technology is a tool to generate sounds. It is recommended
that this tool be used with appropriate counseling and/or in a tinnitus
management program to relieve patients suffering from tinnitus.
Additional guidance | 29
TINNITUS THERAPY CONCEPTS AND BENEFITS Multiflex Tinnitus Technology can be
used as a part of a tinnitus treatment program.
Multiflex Tinnitus Technology plays a white noise through the hearing aid.
Multiflex Tinnitus Technology is programmed according to your hearing loss and
preference, and your hearing care professional can adjust the settings of
Multiflex Tinnitus Technology to meet your needs.
Multiflex Tinnitus Technology may provide temporary relief of your tinnitus.
PRESCRIPTION USE ONLY
CAUTION: Federal law restricts this hearing aid to sale by or on the order of
a doctor,
audiologist or other hearing care professional licensed to dispense hearing
aids in your state.
The use of any sound generating tinnitus therapy instrument should be only on
the advice and in consultation with your audiologist or hearing care
professional. Your hearing professional will properly diagnose and fit the
hearing aid to your personal needs and requirements. This should include its
use in a prescribed tinnitus treatment program.
Your hearing care professional will also be able to offer the appropriate
follow-up care .It is important that you follow your hearing care
professional’s advice and direction regarding such care.
CAUTION: If set to the maximum output level and worn for periods of time
exceeding the
recommendations below, your exposure to sound energy has the potential to
exceed noise exposure limits. You should not use your hearing aid for more
than sixteen (16) hours a day if your hearing aid is set at the maximum output
level, nor should you use your hearing aid if your hearing care professional
has set the hearing aid at levels that exceed your comfort level.
Important Notice for Prospective Sound Generator Users Good health practice
requires that a person with tinnitus have a medical evaluation by a licensed
physician (preferably a physician who specializes in diseases of the ear)
before using a sound generator. Licensed physicians who specialize in diseases
of the ear are often referred to as otolaryngologists, otologists or
otorhinolaryngologists.
The purpose of a medical evaluation is to assure that all medically treatable
conditions that may affect tinnitus are identified and treated before the
sound generator instrument is used.
TINNITUS TECHNICAL DATA Multiflex Tinnitus Technology Maximum Output = 87 dB
SPL (typical) when measured in a 2cc coupler per ANSI S3.22 or IEC 60118-7.
WIRELESS TECHNICAL DESCRIPTION Your hearing aids contain a radio transceiver
utilizing Bluetooth® Low Energy wireless technology operating in the
2.4-2.4835 GHz frequency band with a maximum effective radiated power of -2.5
dBm using GFSK modulation. The receiver section of the radio has a bandwidth
of 1.5 MHz. The RIC 312 also contains a radio transceiver utilizing Near Field
Magnetic Induction operating on 10.281 MHz with maximum induced magnetic field
strength of -5 dBuA/m at a measurement distance of 10 meters with 8-DPSK
modulation. The RIC 312 receiver section of the NFMI radio has a bandwidth of
400 kHz.
30 | Additional guidance
This hearing aid model has been tested to, and has passed, the following
emissions and immunity tests: · IEC 60601-1-2 radiated emissions requirements
for a Group 1 Class B device as stated in CISPR 11. · RF radiated immunity at
a field level of 10 V/m between 80 MHz and 2.7 GHz as well as higher field
levels from communications devices as stated in Table 9 of IEC 60601-1-2. ·
Immunity to power frequency magnetic fields at a field level of 30 A/m, as
well as proximity magnetic
fields as defined in table 11 of 60601-1-2. · Immunity to ESD levels of +/- 8
kV conducted discharge and +/- 15 kV air discharge. The expected service life
is 3 years.
WIRELESS NOTICES RIC 312: FCC ID: EOA-24EDGR312 IC: 6903A-24EDGR312 (Edge AI
RIC 312, Vitality AI RIC 312) 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 user 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.
FCC information
These devices comply with part 15 of the FCC rules and with ISED Canada
license-exempt RSS standards. Operation is subject to the following two
conditions: (1) The 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. Hereby, Starkey Laboratories, Inc.
declares that the RIC 312 is in compliance with the essential requirements and
other relevant provisions of Directive 2014/53/EU.A copy of the Declaration of
Conformity can be obtained from the address below or from
docs.starkeyhearingtechnologies.com. Hereby, Starkey Laboratories, Inc.
declares that the RIC 312 are in compliance with the UK Radio Equipment
Regulations SI 2017 as amended. A copy of the UK Declaration of Conformity can
be obtained from the following addresses and from
docs.starkeyhearingtechnologies.com.
Additional guidance | 31
Regulatory information
For service or repair, please contact your hearing care professional first. If
necessary, you can send your hearing aids to:
Starkey Laboratories, Inc. 6700 Washington Ave. South Eden Prairie, MN 55344
USA www.starkey.com
Starkey Laboratories (Germany) GmbH Weg beim Jäger 218-222 22335 Hamburg
Germany UK Authorised Person: Starkey UK William F. Austin House Pepper Rd,
Hazel Grove Stockport SK7 5BX, UK www.starkey.co.uk
Waste from electronic equipment must be handled according to local regulations
Consult user manual
Keep dry
Instructions for Disposal of Old Electronics Starkey Laboratories, Inc.
encourages, the EU requires, and your local community laws may require, that
your hearing aids be disposed of via your local electronics recycling/disposal
process. At the benefit of disposal/recycling personnel, please remove zinc
air battery from the battery compartment according to the instructions in the
battery section prior to recycling. In addition, please include this user
manual when disposing of your hearing aids.
32 | Additional guidance
Symbol
Symbol Meaning
Applicable Standard
Symbol Number
Manufacturer
BS EN ISO 15223-1:2021
5.1.1
Authorized representative in the European Community
BS EN ISO 15223-1:2021
5.1.2
Date of Manufacture
BS EN ISO 15223-1:2021
5.1.3
Catalogue Number
BS EN ISO 15223-1:2021
5.1.6
Serial Number
BS EN ISO 15223-1:2021
5.1.7
Medical Device
BS EN ISO 15223-1:2021
5.7.7
Keep Dry
BS EN ISO 15223-1:2021
5.3.4
Temperature Limit
BS EN ISO 15223-1:2021
5.3.7
Humidity Limitation
BS EN ISO 15223-1:2021
5.3.8
Caution
BS EN ISO 15223-1:2021
General warning sign
EC 60601-1, Reference no. Table D.2, Safety sign 2
Refer to instruction manual/booklet
EC 60601-1, Reference no. Table D.2, Safety sign 10
Collect Separately
DIRECTIVE 201 2/19/EU (WEEE)
Class II equipment
IEC 60417 Reference no. Table D.1
Regulatory Compliance Mark (RCM)
AS/NZS 4417.1:2012
Giteki Mark
Japanese Radio Law
Direct current Recycling Symbol
IEC 60601-1 Reference no. Table D.1
European Parliament and Council Directive 94/62/EC
5.4.4 ISO 7010-W001 ISO 7010-M002 Annex IX Symbol 9 (IEC 60417- 5172) N/A N/A IEC 60417-5031 Annex I-VII
Notes
Notes
Use of the Made for Apple badge means that an accessory has been designed to
connect specifically to the Apple product(s) identified in the badge, and has
been certified by the developer to meet Apple performance standards. Apple is
not responsible for the operation of this device or its compliance with safety
and regulatory standards. Apple, the Apple logo, iPhone, iPad and iPod touch
are trademarks of Apple Inc., registered in the U.S. and other countries. iOS
is a trademark or registered trademark of Cisco in the U.S. and other
countries and is used under license.
Google Play is a trademark of Google LLC.
The Bluetooth® word mark and logos are registered trademarks owned by
Bluetooth SIG, Inc. and any use of such marks by Starkey is under license.
Multiflex Tinnitus and Starkey are trademarks of Starkey Laboratories, Inc.
©2024 Starkey Laboratories, Inc. All Rights Reserved. P00002032 4/24
BKLT3197-02-EN-XX Patent: www.starkey.com/patents
References
- Students & Faculty: Starkey University| StarkeyPro
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA
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