(36 days)
Not Found
No
The device description focuses on pre-recorded audio content and a standard MP3 player, with no mention of adaptive algorithms, learning, or AI/ML components.
Yes
The device is indicated for adult tinnitus sufferers and uses specific sound therapy to manage tinnitus, which is a medical condition. It also requires direction from a healthcare professional.
No
The device is indicated for tinnitus management by providing sounds to mask or intermittently mask tinnitus, not for diagnosing it. Diagnosis of the underlying cause of tinnitus is performed by a physician prior to using this device.
No
The device description explicitly includes hardware components: two mini compact disks, a portable stereo MP3 mini compact disc player, and earphones.
Based on the provided information, the TinniTech ANMP System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- TinniTech ANMP System Function: The TinniTech ANMP System is a sound therapy device. It delivers spectrally adjusted music and noise to the patient's ears to help manage tinnitus. It does not analyze any biological specimens from the patient.
- Intended Use: The intended use is for the management of tinnitus in adult sufferers, not for diagnosing a condition based on laboratory analysis of samples.
Therefore, the TinniTech ANMP System falls under the category of a therapeutic or sound therapy device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TinniTech ANMP System comprises two (2) mini compact disks that have been prerecorded with selected relaxation music and other sounds spectrally adapted to suit the particular patient's hearing thresholds. The device is indicated to mask and intermittently mask tinnitus as part of a tinnitus management program. The addition of the music is to aid the promotion of relaxation during the tinnitus masking process.
The spectral adaptation of the sound is determined by the patient's audiogram measured by a qualified audiologist; the patient's tinnitus therapy is managed by an appropriate healthcare professional. The target population for the device is adults (18 years of age and over) who present with tinnitus that may or may not be accompanied with hearing loss at the higher frequencies.
Product codes (comma separated list FDA assigned to the subject device)
KLW
Device Description
The TinniTech ANMP system consists of:
One CD pre-recorded in the MP3 format with selected relaxation music and superimposed low amplitude, wide spectrum noise that is spectrally adapted to compensate for the individual patient's higher frequencies hearing loss. This CD is intended for the complete masking of tinnitus.
One CD pre-recorded in the MP3 format with selected relaxation music that is spectrally adapted to compensate for the individual patient's higher frequencies hearing loss however this CD has been recorded such that the dynamic characteristics of the sound allow the tinnitus to intermittently break through during the quieter passages of the recorded music.
A commercially available, battery powered, stereo, MP3 mini compact disc player with earphones with a performance specification that TinniTech has tested and shown to be suitable for the delivery of the ANMP treatment sounds or waveforms. At this time Tinnitech will supply the Phillips eXpanium 401™ MP3 mini compact disc player. Other suitable players will be offered as TinniTech tests and approves them for the ANMP System.
The components of the complete TinniTech ANMP system include: Sound files on storage means (digital mini CDs) A high quality, digital MP3 mini CD player, of normal commercial supply User's Manual
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults (18 years of age and over)
Intended User / Care Setting
Home use under the direction of an appropriately qualified healthcare professional such as an otolaryngologist, an audiologist, or a licensed hearing aid dealer.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.3400 Tinnitus masker.
(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.
0
KO30791
APR 1 7 2003
510(k) SUMMARY
TinniTech ANMP System
| Applicant: | TinniTech Ltd
Level 2, 55 Market Street
Sydney NSW 2000
Australia
Phone: +61 2 9283 0601
Fax: +61 2 9283 0602 |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Date of
Submission: | 28 February 2003 |
| Manufacturing Site: | ResMed Ltd.
97 Waterloo Road
North Ryde NSW 2113
Australia |
| Establishment
Registration
Number: | 8020057 |
| Distributor: | Mr R West, Go West, Inc.
2502 Tournament Court
Castle Rock, CO 80104
Phone/Fax: (303) 663-8089 |
| Contact Name for
Submission: | Lachlan James
(contact address as per Applicant) |
| Trade or
Proprietary Name | ANMP (Acoustic Neuro Modulation Protocol) |
| Common or Usual
Names | Tinnitus Masker |
| Classification Name
(FDA) | KLW : Masker Tinnitus |
| Classification | Class II device |
Comments of the comments of
1
Indications for Use:
The TinniTech ANMP System comprises two (2) mini compact disks that have been prerecorded with selected relaxation music and other sounds spectrally adapted to suit the particular patient's hearing thresholds. The device is indicated to mask and intermittently mask tinnitus as part of a tinnitus management program. The addition of the music is to aid the promotion of relaxation during the tinnitus masking process.
The spectral adaptation of the sound is determined by the patient's audiogram measured by a qualified audiologist; the patient's tinnitus therapy is managed by an appropriate healthcare professional. The target population for the device is adults (18 years of age and over) who present with tinnitus that may or may not be accompanied with hearing loss at the higher frequencies.
Intended use
The ANMP System is intended to completely mask and intermittently mask tinnitus as part of a tinnitus management program. The addition of the music is to aid the promotion of relaxation during the tinnitus masking process. The initial hearing and tinnitus tests are conducted by a qualified audiologist familiar with the treatment of tinnitus: the subsequent management of the treatment is carried out by an appropriate healthcare professional.
Target population
The target population for the device is adults (18 years and over) who present with tinnitus that may or may not be accompanied with hearing loss at the higher frequencies and who are participating in a tinnitus management program.
Device description
The TinniTech ANMP system consists of:
One CD pre-recorded in the MP3 format with selected relaxation music and superimposed low amplitude, wide spectrum noise that is spectrally adapted to compensate for the individual patient's higher frequencies hearing loss. This CD is intended for the complete masking of tinnitus.
One CD pre-recorded in the MP3 format with selected relaxation music that is spectrally adapted to compensate for the individual patient's higher frequencies hearing loss however this CD has been recorded such that the dynamic characteristics of the sound allow the tinnitus to intermittently break through during the quieter passages of the recorded music.
2
A commercially available, battery powered, stereo, MP3 mini compact disc player with earphones with a performance specification that TinniTech has tested and shown to be suitable for the delivery of the ANMP treatment sounds or waveforms. At this time Tinnitech will supply the Phillips eXpanium 401™ MP3 mini compact disc player. Other suitable players will be offered as TinniTech tests and approves them for the ANMP System.
Substantial equivalence
TenniTech is claiming substantial equivalence to two devices:
Equivalence is claimed to the Dynamic Tinnitus Mitigation System, DTM-6 manufactured by Petroff Audio Technologies Inc. 510k number; K974501
Equivalence is also claimed to the Custom TCI Instrument manufactured by Siemens Hearing Instruments, 510k number; K011364.
K974501
The Dynamic Tinnitus Mitigation System, DTM-6 manufactured by Petroff Audio Technologies Inc. 510k number; K974501 is a four (4) CD set system capable of being played on any commercial CD player with headphones or speakers. CD#1 provides digital tinnitus masking sounds only, CDs #2, #3 and #4 provide digital tinnitus masking sounds plus relaxation messages, alpha rhythms (a gentle musical sound generated on electronic musical instruments), music and/or nature sounds. CDs #2. #3 and #4 add the indication of promoting relaxation during the tinnitus masking process to the indication of providing 'temporary relief of tinnitus symptoms'.
Like the predicate device K974501 the TinniTech ANMP sounds are recorded on mini CDs (in the MP3 format) capable of being played on any one of a number of good quality, portable MP3 mini disc players, the patient using appropriate earphones to listen to the sound recorded on the discs.
The TinniTech ANMP, like CDs #2. #3 and #4 of the predicate device includes on CD1 digital tinnitus masking sounds together with selected musical sounds to promote relaxation during the tinnitus continuous masking process.
K011364
The Custom TCI Instrument manufactured by Siemens Hearing Instruments, 510k number: K011364. is a fully digital. low level noise generator. The device is programmable, with selected noise and output levels and is indicated for use in the delivery of tinnitus habituation and tinnitus masking therapies.
The output noise in the Custom TCI Instrument can be custom-tailored to the user's individual requirements.
3
Like the predicate device, K011364, the TinniTech ANMP custom-tailors the sounds on both CD 1 and CD 2 to suit the individual patients' hearing requirements. This is achieved analysing the patient's audiogram and boosting the amplitude of those sounds or tones where the patient has been shown to have a reduced hearing threshold.
The TinniTech ANMP also includes on CD 2 specially selected music with a dynamic characteristic that allows the patient's tinnitus sound to intermittently break through the masking effect of the music. This function, like the predicate device K011364, assists in enhancing the patient's habituation to the tinnitus sound.
4
| Characteristic | New Device | Predicate Device
K974501 | Predicate Device
K011364 |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Continuously and
intermittently mask
tinnitus as part of a
tinnitus management
program with masking
noise and selected
music to promote the
relaxation of the
patient during the
delivery of the
Tinnitech ANMP
therapy. | Temporary relief of
tinnitus symptoms and
the promotion of
relaxation during the
tinnitus masking
process. | Continuously mask
and partially mask
tinnitus as part of a
tinnitus management
program. |
| Target Population | Adults (18 years and
over), both with and
without high
frequency loss, with
tinnitus who are
participating in a
tinnitus management
program. | All tinnitus sufferers,
including that
percentage of severe
sufferers who are "un-
maskable" through the
application of a
masking sound. | Adults and children
(over 5 years of age)
with tinnitus who are
participating in a
tinnitus |
| Audio signal
technology | Digital | Digital | Digital |
| Available
noises/sounds | Pre-adapted to the
patient's hearing
characteristics,
a wide selection of
musical sounds
incorporating Tinnitus
Masking noise (20Hz
- 20KHz) digitally
recorded on mini
compact discs in MP3
format. | Proprietary dynamic
formats of sounds
incorporating Dynamic
Tinnitus Mitigation
technology (20Hz -
20KHz) recorded on
digital storage means
that are played at
audible levels. | Programmable noise
spectrum with pre-
selection of four noise
types digitally stored
in solid state memory. |
| Medium | Two mini CDs (but
could be expanded by
providing a variety of
music on additional
discs). | Four CDs/audio tapes | Solid state memory. |
| Characteristic | New Device | Predicate Device
K974501 | Predicate Device
K011364 |
| Operation - continued | | | |
| Volume control | Yes, user controlled
with warning in the
User Instruction
Manual stating "To
prevent the possible
damage to your
hearing the volume
setting of the disc
player should not be
set at levels where
you are uncomfortable
with the sound". | Yes, user controlled
with a note stating
that the volume
should always be set
at a low level when
first trying any CD. | Yes, user controlled
within limits pre-
programmed by the
managing health
professional. |
| Distribution | To be sold via direct
and indirect channels
involving an
appropriately qualified
healthcare
professional. | Currently sold and
supported via mail
order. | The sale and fitting of
the Siemens Custon
TCI will only be
conducted through a
Hearing Healthcare
Professional, such as
an audiologist or
otolaryngologist. |
| Components | The components of
the complete
TinniTech ANMP
system include:
Sound files on
storage means
(digital mini CDs)A high quality,
digital MP3 mini
CD player, of
normal
commercial
supplyUser's Manual | The components of
the complete
predicate device
system include:
Sound files on
storage means
(digital CDs or
Audio tapes)A digital CD or
Audio Tape
player, either
portable or fixed
of normal
commercial
supply or pre-
existing in the
home or car.User's Manual (called
Workbook) | The Siemens Custom
TCI is a fully digital,
programmable, low
level noise generator
that is available in a
full in-the-ear, half
shell, in-the-canal, or
helix shell.
User's Manual. |
| Characteristic | New Device | Predicate Device
K974501 | Predicate Device
K011364 |
| Audio player device. | The Philips eXpanium
401 mini MP3 mini CD
player with earphones
is supplied by
TinniTech
Size
3.6"L x 4.7" H x
1.1" D
Weight: 200 g (7.1
ounces)
Battery: 1 x 1.5V AA
Accessories:
Earphone | A standard Walkman
type digital player or
equivalent player is a
commonly used
listening/delivery
device.
The Sony model
CDFV-15 is
recommended.
Size:
5.5" x 5.0" x 7/8"
Weight: 105 g
(3.6 ounces)
Battery: 2 x 1.5V AA
Accessories:
headphones | Not applicable. |
| Energy delivered | The supplied mini disc
player, the Philips
eXpanium 401 has a
maximum power
output per channel of
5mW.
The maximum output
from the earphones
could exceed 85 dBA,
the OSHA (Standard
29CFR 1910.95) 8
hour time weighted
average for the
occupational
workplace, and
therefore a warning
about setting the
player volume setting
at a comfortable
(safe) level is included
in the User's Manual
and on the player | No Maximum
stipulated or
controlled. A home
stereo system could
be capable of more
than 200 Watts
output. | Maximum output is
86dBA which exceeds
the OSHA (Standard
29CFR 1910.95) 8
hour time weighted
average for the
occupational
workplace therefore
warnings are included
in the User's Manual. |
| Energy used | The supplied mini disc
player, the Philips
eXpanium 401
operates from either
one AA cell or a 110
VAC mains adapter
provided with the
player. | The audio player will
utilise mains voltage
(1110 VAC) or battery
voltage (typically up
to 9 VDC) | Small hearing aid type
battery. |
| Characteristic | New Device | Predicate Device
K974501 | Predicate Device
K011364 |
| Transducer
(headphones type) | Use the earphones
provided with the mini
disc player. | Recommended to use
either Radio Shack
headphones PRO-35
or
Sony premium
headphones or
earbuds. | The Siemens Custom
TCI is an "in-the-ear"
device and is
available in four
versions:
full in-the-ear, half
shell, in the canal, or
helix shell. |
| Where used | Home use under the
management of an
appropriately qualified
healthcare
professional | Home use | Home use |
| Safety | The ANMP therapy
should never be
undertaken when the
tinnitus masking
sounds might prevent
the patient from
hearing cues or
warnings of likely
harm or danger. | External low-level
noise may not be
heard due to the fact
that the soundwaves
are played at audible
levels to suppress
Tinnitus | |
| Materials | Typical audio product
materials such as
plastic and diecast
metals. | Typical audio product
materials such as
plastic and diecast
metals. | Typical hearing ail
product materials
such as plastics. |
| Performance | The TinniTech ANMP
system enables the
user to determine
whether the delivered
therapy assists in the
management of their
tinnitus. | The predicate device
enables the user to
determine whether the
sound therapy assists
them manage their
tinnitus | The predicate device
enables the end user
to determine whether
the sound therapy
assists them to
suppress Tinnitus. |
| Instructions | The TinniTech ANMP
System comes with a
User's Guide | The predicate device
comes with a 23 page
Workbook | |
5
6
7
8
Treatment management and diagnosis
The TinniTech ANMP System is for home use under the direction of an appropriately qualified healthcare professional such as an otolaryngologist, an audiologist, or a licensed hearing aid dealer.
Patients should receive a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) to rule out medically or surgically treatable diseases for which tinnitus is a symptom before proceeding with the TinniTech ANMP treatment.
Risks and warnings for safe use
The maximum output could exceed the occupational workplace OSHA standard 29CFR 1910.95 of 85 dBA. To avoid possible hearing damage the CD player and the User's Manual carry warnings stating that the sounds on the discs should not be played at uncomfortable volume levels.
The CD player carries a label warning against use of the ANMP system if such use prevents the user from hearing sounds warning of danger.
Benefits
Relief from the effects of tinnitus may be provided by the TinniTech ANMP system when used within a tinnitus management program.
9
Image /page/9/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three parallel lines curving upwards, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2003
TinniTech Ltd c/o Lachlan S. James Level 2, 55 Market Street Sydney NSW 2000 Australia
Re: K030791
Trade/Device Name: ANMP (Acoustic Neuro Modulation Protocol) Regulation Number: 21 CFR §874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: February 28, 2003 Received: March 12, 2003
Dear Mr. James:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
10
Page 2 - Lachlan S. James
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. halyi Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
11
3.2 Indications for Use
510(k) Number (if known): Device Name: TinniTech ANMP System:
KO30791
Indications for Use:
The TinniTech ANMP System comprises two (2) mini compact disks and a portable, stereo, MP3 mini compact disc player with earphones. The discs have been prerecorded with selected relaxation music and other sounds spectrally adjusted to suit the particular patient's spectral hearing thresholds as shown by their audiogram. The sounds on the discs are reproduced by the mini compact disc player and delivered to the ears by the earphones supplied with the player. The device is indicated for adult (18 years and over) tinnitus sufferers who may or may not suffer higher frequencies hearing loss and are participating in a tinnitus management program.
The TinniTech ANMP System is for home use under the direction of an appropriately qualified healthcare professional such as an otolaryngologist, an audiologist, or a licensed hearing aid dealer.
Patients should receive a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) to rule out medically or surqically treatable diseases for which tinnitus is a symptom before proceeding with non-medical tinnitus management.
The Tinnitech ANMP System may be used to completely mask and intermittently mask tinnitus.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| --------------------------------------- | --- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Division Sign-Off)
Division of Ophthalmic Ear, Nose and Throat Devises
| 510(k) Number | K030791 |
|---|---|
| --------------- | --------- |
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