(267 days)
Not Found
No
The summary describes a digital noise generator and hearing aid with programmable settings, but there is no mention of AI or ML technology being used for signal processing, adaptation, or any other function. The programming is done manually via software.
Yes
The device is intended to treat chronic persistent ringing in the ears (Tinnitus) and provides amplification for hearing loss, indicating a therapeutic purpose.
No
The device is described as a "noise generator and hearing aid" intended for Tinnitus Retraining Therapy (TRT) and amplification. Its function is to produce sound and amplify hearing, not to diagnose medical conditions or analyze patient data for diagnostic purposes.
No
The device description explicitly states it is housed in standard In-the-ear or behind-the-ear instrument housings, indicating it includes physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a combination of a digital noise generator and a hearing aid. Its intended use is to address tinnitus and provide amplification for hearing loss.
- The device interacts directly with the patient's auditory system by generating sound and amplifying external sounds. It does not analyze biological samples.
Therefore, this device falls under the category of a medical device but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The combined devices are intended for the adult population suffering from a chronic persistent ringing in the ears (Tinnitus), who also need or desire amplification. The amplification suits the needs of a of a slight to a profound hearing loss (see table below). The products may also be used for masking Tinnitus as part of a Tinnitus Retraining Therapy (TRT) protocol and should be utilized only in consultation with a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist.
Product codes (comma separated list FDA assigned to the subject device)
ESD, KLW
Device Description
The above mentioned TRT devices are digital noise generators and hearing aids which were developed to be used in a tinnitus retraining therapy. These products have up to four different programs, which can be programmed in shape and level to fit the individual users needs. The programming can be done with a standard HI-PRO and the audifit software. Within the software the amplification of the combi-masker can be fitted to the individual needs. The noise can be adjusted in shape with low- and high-cut filters and in the output level. It is housed in a standard In-the-ear instrument housing (CIC, IS+ housing) or in a standard behind-the-ear instrument housing (S, S+, M and X housing).
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
Adult population
Intended User / Care Setting
licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. May be used anywhere.
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)
The non-clinical performance data which were measured according to official standards (ANSI S3.22-2009) verify that the devices have a similar effectiveness as the predicate device, For TRT therapy only low sound levels below 80 dB SPL are needed. So for an effective TRT system levels above this are not needed. Also according the OSHA (29CFR 1910.95) output levels should not exceed 85 dBA. Therefore a warning in the software will occur that the higher levels should not be used or only in case of a hearing loss. So the lower maximum output has no influence on the effectiveness of the devices.
The frequency range provides an equivalent white noise with the same sound quality.
In conclusion the non-clinical tests demonstrate that the submitted devices are as safe, as effective, and perform as well as the predicate device.
The submission for tinnitus masker relies on a special control that is defined in section 874.3400. The special controls are identical applied as with the predicate device and supports the substantial equivalence.
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
KB0514
5 510(k) Summary
-
- Applicant's Name and Address:
audifon USA Inc. 403 Chairman Ct., Suite 1 Debary, Florida 32713 PO BOX 531700 USA
- Applicant's Name and Address:
-
Contact Person: Jane E Perrone Phone: 386-6688812
-
Trade or Proprietary Name:
audifon arriva CIC TRT audifon arriva IS TRT audifon arriva IS+ TRT audifon arriva M TRT audifon arriva S TRT audifon arriva S+ TRT audifon arriva X TRT audifon elia CIC TRT audifon elia IS TRT audifon elia IS+ TRT audifon elia M TRT audifon elia S TRT audifon prado CIC TRT audifon prado IS TRT audifon prado IS+ TRT audifon prado M TRT audifon prado S TRT audifon vico CIC TRT audifon vico IS TRT audifon vico IS+ TRT audifon vico M TRT audifon vico S TRT
Hearing Aid, Tinnitus Masker (Regulation Number: 21 CFR 874.3400)
-
- Device Common Name / Classification Name:
ડ. Product Code: ESD, KLW
- Device Common Name / Classification Name:
-
- Classification of Device:
Class I for hearing aid Class II for tinnitus masker
- Classification of Device:
-
- Establishment Registration Number:
3005384855
- Establishment Registration Number:
NOV 2 1 2013
1
audifon GmbH & Co. KG Werner-von-Siemens.Str. 2 D-99625 Kölleda Germany
- Market Device with Substantial Equivalence: K091552 audifon switch 8 TRT
Date of Preparation 10.
November 07, 2013
2
Indications for Use
The combined devices are intended for the adult population suffering from a chronic persistent ringing in the ears (Tinnitus), who also need or desire amplification. The amplification suits the needs of a of a slight to a profound hearing loss (see table below). The products may also be used for masking Tinnitus as part of a Tinnitus Retraining Therapy (TRT) protocol and should be utilized only in consultation with a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist.
| Device Name | Hearing loss level |
|---|---|
| arriva CIC TRT | slight to moderate severe |
| arriva IS TRT | slight to moderate severe |
| arriva IS+ TRT | slight to moderate severe |
| arriva M TRT | slight to severe |
| arriva S TRT | slight to severe |
| arriva S+ TRT | slight to severe |
| arriva X TRT | mild to profound |
| elia CIC TRT | slight to moderate severe |
| elia IS TRT | slight to moderate severe |
| elia IS+ TRT | slight to severe |
| elia M TRT | mild to profound |
| elia S TRT | slight to severe |
| prado CIC TRT | slight to moderate severe |
| prado IS TRT | slight to moderate severe |
| prado IS+ TRT | slight to moderate severe |
| prado M TRT | mild to profound |
| prado S TRT | slight to severe |
| vico CIC TRT | slight to moderate severe |
| vico IS TRT | slight to moderate severe |
| vico IS+ TRT | slight to severe |
| vico M TRT | mild to profound |
| vico S TRT | slight to severe |
Description of Device
The above mentioned TRT devices are digital noise generators and hearing aids which were developed to be used in a tinnitus retraining therapy. These products have up to four different programs, which can be programmed in shape and level to fit the individual users needs. The programming can be done with a standard HI-PRO and the audifit software. Within the software the amplification of the combi-masker can be fitted to the individual needs. The noise can be adjusted in shape with low- and high-cut filters and in the output level. It is housed in a standard In-the-ear instrument housing (CIC, IS+ housing) or in a standard behind-the-ear instrument housing (S, S+, M and X housing).
3
Comparison Information to Predicate Device
The mentioned devices are substantially equivalent to the audifon switch 8 TRT (K091552). The mentioned devices and the audifon switch 8 TRT are fully digital noiser, with programmable noises. Within the program the level and the shape of the noise can be adjusted. Also the mentioned devices and the switch 8 TRT provide an additional amplification and can be programmed with the fitting software and a standard HI-PRO programming box.
The non-clinical performance data which were measured according to official standards (ANSI S3.22-2009) verify that the devices have a similar effectiveness as the predicate device, For TRT therapy only low sound levels below 80 dB SPL are needed. So for an effective TRT system levels above this are not needed. Also according the OSHA (29CFR 1910.95) output levels should not exceed 85 dBA. Therefore a warning in the software will occur that the higher levels should not be used or only in case of a hearing loss. So the lower maximum output has no influence on the effectiveness of the devices.
The frequency range provides an equivalent white noise with the same sound quality.
In conclusion the non-clinical tests demonstrate that the submitted devices are as safe, as effective, and perform as well as the predicate device.
The submission for tinnitus masker relies on a special control that is defined in section 874.3400. The special controls are identical applied as with the predicate device and supports the substantial equivalence:
The following tables compare the submitted devices and the audifon switch 8 TRT.
4
| | audifon arriva CIC TRT
audifon arriva IS TRT
audifon arriva IS+ TRT
audifon arriva M TRT
audifon arriva S TRT
audifon arriva S+ TRT
audifon arriva X TRT | switch 8 TRT |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For
Use | The combined devices are intended for the adult
population suffering from a chronic persistent
ringing in the ears (Tinnitus), who also need or
desire amplification. The amplification suits the
needs of a slight to a profound hearing loss. The
products may also be used for masking Tinnitus
as part of a Tinnitus Retraining Therapy (TRT)
protocol and should be utilized only in
consultation with a licensed hearing healthcare
professional, who is trained in subsequent
rehabilitation therapy, or a qualified audiologist. | The device is addressed to the adult population
with a chronic persistent ringing in the ears
(Tinnitus), who also need or desire amplification.
The amplification suits the needs of a mild to a
moderate hearing loss. It may be used for
masking tinnitus as part of tinnitus management
program that is prescribed by a licensed hearing
healthcare professional, who is trained in
subsequent rehabilitation therapy, or a qualified
audiologist. Therefore it generates a broadband
noise with sufficient bandwidth and intensity and
is applied on the ear. |
| Operation /
Mechanism | Uses broadband noise; Manages tinnitus through
masking and distraction
Circuit type:
Digital
Programmable:
Yes
Available noises:
Four
Volume control:
Yes (M, S, S+ X)
Optional (CIC, IS, IS+) | Uses broadband noise; Manages tinnitus through
masking and distraction
Circuit type:
Digital
Programmable:
Yes
Available noises:
Four
Volume control:
No |
| | white-noise is adjustable
noise level is programmable
adjustable Low Battery Indicator
programmable Program Switch Tones | white-noise is adjustable
noise level is programmable
adjustable Low Battery Indicator
programmable Program Switch Tones |
| Where Used | May be used anywhere | May be used anywhere |
| Physical
Description | Standard In-the-ear instrument housing
(CIC, IS and IS+ housing)
Standard behind-the-ear instrument housing
(M, S, S+ and X housing) | Standard receiver-in-the-ear instrument housing |
| | RMS Output Characteristics: | RMS Output Characteristics: |
| Maximum
Output | White noise:
70 - 74 dB SPL | White noise:
100 dB SPL |
| Characteristics | frequency range:
200 - 8000 Hz | frequency range:
200 - 6000 Hz |
| Power Source | standard 10 zinc air 1,4V hearing aid battery
(CIC housing)
standard 312 zinc air 1,4V hearing aid battery
(IS and S housing)
standard 13 zinc air 1,4V hearing aid battery
(IS+, M and S+ housing)
standard 675 zinc air 1,4V hearing aid battery
(X housing) | Uses standard 312 zinc air 1.4V hearing aid
battery |
| Quality
Assurance
Standard | ANSI S3.22-2009 to ensure proper functioning of
HA | ANSI S3.22-2009 to ensure proper functioning of
HA |
.
5
| | audifon elia CIC TRT
audifon elia IS TRT
audifon elia IS+ TRT
audifon elia M TRT
audifon elia S TRT | switch 8 TRT |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For
Use | The combined devices are intended for the adult
population suffering from a chronic persistent
ringing in the ears (Tinnitus), who also need or
desire amplification. The amplification suits the
needs of a slight to a profound hearing loss. The
products may also be used for masking Tinnitus
as part of a Tinnitus Retraining Therapy (TRT)
protocol and should be utilized
only
in
consultation with a licensed hearing healthcare
professional, who is trained in subsequent
rehabilitation therapy, or a qualified audiologist. | The device is addressed to the adult population
with a chronic persistent ringing in the ears
(Tinnitus), who also need or desire amplification.
The amplification suits the needs of a mild to a
moderate hearing loss. It may be used for
masking tinnitus as part of tinnitus management
program that is prescribed by a licensed hearing
healthcare professional, who is trained in
subsequent rehabilitation therapy, or a qualified
audiologist. Therefore it generates a broadband
noise with sufficient bandwidth and intensity and
is applied on the ear. |
| | Uses broadband noise; Manages tinnitus through
masking and distraction | Uses broadband noise; Manages tinnitus through
masking and distraction |
| Operation /
Mechanism | Circuit type:
Digital
Programmable:
Yes
Available noises:
Four
Volume control:
Yes (M, S)
Optional (IS, IS+)
No (CIC) | Circuit type:
Digital
Programmable:
Yes
Available noises:
Four
Volume control:
No |
| | white-noise is adjustable
noise level is programmable
adjustable Low Battery Indicator
programmable Program Switch Tones | white-noise is adjustable
noise level is programmable
adjustable Low Battery Indicator
programmable Program Switch Tones |
| Where Used | May be used anywhere | May be used anywhere |
| Physical
Description | Standard In-the-ear instrument housing
(CIC, IS and IS+ housing)
Standard behind-the-ear instrument housing
(M, and S housing) | Standard receiver-in-the-ear instrument housing |
| Maximum
Output | RMS Output Characteristics: | RMS Output Characteristics: |
| Characteristics | White noise:
71 - 72 dB SPL | White noise:
100 dB SPL |
| | frequency range:
200 - 8000 Hz | frequency range:
200 - 6000 Hz |
| Power Source | standard 10 zinc air 1,4V hearing aid battery
(CIC housing)
standard 312 zinc air 1,4V hearing aid battery
(IS and S housing)
standard 13 zinc air 1,4V hearing aid battery
(IS+, and M housing) | Uses standard 312 zinc air 1.4V hearing aid
battery |
| Quality
Assurance
Standard | ANSI S3.22-2009 to ensure proper functioning of
HA | ANSI S3.22-2009 to ensure proper functioning of
HA |
| | audifon prado CIC TRT
audifon prado IS TRT
audifon prado IS+ TRT
audifon prado M TRT
audifon prado S TRT | switch 8 TRT |
| Indications For
Use | The combined devices are intended for the adult
population suffering from a chronic persistent
ringing in the ears (Tinnitus), who also need or
desire amplification. The amplification suits the
needs of a slight to a profound hearing loss. The
products may also be used for masking Tinnitus
as part of a Tinnitus Retraining Therapy (TRT)
protocol and should be utilized only in
consultation with a licensed hearing healthcare
professional, who is trained in subsequent
rehabilitation therapy, or a qualified audiologist. | The device is addressed to the adult population
with a chronic persistent ringing in the ears
(Tinnitus), who also need or desire amplification.
The amplification suits the needs of a mild to a
moderate hearing loss. It may be used for
masking tinnitus as part of tinnitus management
program that is prescribed by a licensed hearing
healthcare professional, who is trained in
subsequent rehabilitation therapy, or a qualified
audiologist. Therefore it generates a broadband
noise with sufficient bandwidth and intensity and
is applied on the ear. |
| | Uses broadband noise; Manages tinnitus through
masking and distraction | Uses broadband noise; Manages tinnitus through
masking and distraction |
| Operation /
Mechanism | Circuit type:
Digital
Programmable:
Yes
Available noises:
Four
Volume control:
Yes (M, S)
Optional (IS, IS+)
No (CIC) | Circuit type:
Digital
Programmable:
Yes
Available noises:
Four
Volume control:
No |
| | white-noise is adjustable
noise level is programmable
adjustable Low Battery Indicator
programmable Program Switch Tones | white-noise is adjustable
noise level is programmable
adjustable Low Battery Indicator
programmable Program Switch Tones |
| Where Used | May be used anywhere | May be used anywhere |
| Physical
Description | Standard In-the-ear instrument housing
(CIC, IS and IS+ housing)
Standard behind-the-ear instrument housing
(M, and S housing) | Standard receiver-in-the-ear instrument housing |
| Maximum | RMS Output Characteristics: | RMS Output Characteristics: |
| Output
Characteristics | White noise:
71 - 72 dB SPL | White noise:
100 dB SPL |
| | frequency range:
200 - 8000 Hz | frequency range:
200 - 6000 Hz |
| Power Source | standard 10 zinc air 1,4V hearing aid battery
(CIC housing)
standard 312 zinc air 1,4V hearing aid battery
(IS and S housing)
standard 13 zinc air 1,4V hearing aid battery
(IS+, and M housing) | Uses standard 312 zinc air 1.4V hearing aid
battery |
| Quality
Assurance
Standard | ANSI S3.22-2009 to ensure proper functioning of
HA | ANSI S3.22-2009 to ensure proper functioning of
HA |
| | audifon vico CIC TRT
audifon vico IS TRT
audifon vico IS+ TRT
audifon vico M TRT
audifon vico S TRT | switch 8 TRT |
| Indications For
Use | The combined devices are intended for the adult
population suffering from a chronic persistent
ringing in the ears (Tinnitus), who also need or
desire amplification. The amplification suits the
needs of a slight to a porfound hearing loss. The
products may also be used for masking Tinnitus
as part of a Tinnitus Retraining Therapy (TRT)
protocol and should be utilized only in
consultation with a licensed hearing healthcare
professional, who is trained in subsequent
rehabilitation therapy, or a qualified audiologist. | The device is addressed to the adult population
with a chronic persistent ringing in the ears
(Tinnitus), who also need or desire amplification.
The amplification suits the needs of a mild to a
moderate hearing loss. It may be used for
masking tinnitus as part of tinnitus management
program that is prescribed by a licensed hearing
healthcare professional, who is trained in
subsequent rehabilitation therapy, or a qualified
audiologist. Therefore it generates a broadband
noise with sufficient bandwidth and intensity and
is applied on the ear. |
| Operation /
Mechanism | Uses broadband noise; Manages tinnitus through
masking and distraction | Uses broadband noise; Manages tinnitus through
masking and distraction |
| | Circuit type:
Digital
Programmable:
Yes
Available noises:
Four
Volume control:
Yes (M, S)
Optional (CIC, IS, IS+)
white-noise is adjustable
noise level is programmable
adjustable Low Battery Indicator
programmable Program Switch Tones | Circuit type:
Digital
Programmable:
Yes
Available noises:
Four
Volume control:
No
white-noise is adjustable
noise level is programmable
adjustable Low Battery Indicator
programmable Program Switch Tones |
| Where Used | May be used anywhere | May be used anywhere |
| Physical
Description | Standard In-the-ear instrument housing
(CIC, IS and IS+ housing)
Standard behind-the-ear instrument housing
(M and S housing) | Standard receiver-in-the-ear instrument housing |
| RMS Output Characteristics: | | RMS Output Characteristics: |
| Maximum
Output
Characteristics | White noise:
107 - 113 dB SPL | White noise:
100 dB SPL |
| | frequency range:
200 - 8000 Hz | frequency range:
200 - 6000 Hz |
| Power Source | standard 10 zinc air 1,4V hearing aid battery
(CIC housing)
standard 312 zinc air 1,4V hearing aid battery
(IS and S housing)
standard 13 zinc air 1,4V hearing aid battery
(IS+, and M housing) | Uses standard 312 zinc air 1.4V hearing aid
battery |
| Quality
Assurance
Standard | ANSI S3.22-2009 to ensure proper functioning of
HA | ANSI S3.22-2009 to ensure proper functioning of
HA |
·
6
.
7
Conclusion
- . The devices have similar acoustic characteristics as the predicate device.
- The devices are similar in style (ITE or BTE) as the predicate device. .
- The devices are similar in material as the predicate device. .
- . The devices are similar in intended use as the predicate device
- The devices have the same targeted population as the predicate device .
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/8/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 21, 2013
Audifon USA, Inc. c/o Ms. Jane E. Perrone Vice President of U.S. Operations 403 Chairman Ct. Suite 1 Debary, FL 32713
Re: K130514
Trade/Device Name: TRT products arriva, vico, prado and elia Regulation Number: 21 CFR 874.3400 Regulation Name: Hearing Aid, Tinnitus Masker Regulatory Class: Class II (for tinnitus masker) Product Code: KLW, ESD Dated: August 19, 2013 Received: August 23, 2013
Dear Ms. Perrone:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
9
Page 2 - Ms. Jane E. Perrone
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
Indications for Use
510(k) Number (if known):
Device Name:
audifon arriva CIC TRT audifon arriva IS TRT audifon arriva IS+ TRT audifon arriva M TRT audifon arriva S TRT audifon arriva S+ TRT audifon arriva X TRT audifon elia CIC TRT audifon elia IS TRT audifon elia IS+ TRT audifon elia M TRT audifon elia S TRT audifon prado CIC TRT audifon prado IS TRT audifon prado IS+ TRT audifon prado M TRT audifon prado S TRT audifon vico CIC TRT audifon vico IS TRT audifon vico IS+ TRT audifon vico M TRT audifon vico S TRT
(hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator) (hearing aid with TRT noise generator)
Indications For Use:
The combined devices are intended for the adult population suffering from a chronic persistent ringing in the ears (Tinnitus), who also need or desire amplification. The amplification suits the needs of a slight to a profound hearing loss (see table below). The products may also be used for masking Tinnitus as part of a Tinnitus Retraining Therapy (TRT) protocol and should be utilized only in consultation with a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist.
Page 1 of 2
11
| Device Name | Hearing loss level |
|---|---|
| arriva CIC TRT | slight to moderate severe |
| arriva IS TRT | slight to moderate severe |
| arriva IS+ TRT | slight to moderate severe |
| arriva M TRT | slight to severe |
| arriva S TRT | slight to severe |
| arriva S+ TRT | slight to severe |
| arriva X TRT | mild to profound |
| elia CIC TRT | slight to moderate severe |
| elia IS TRT | slight to moderate severe |
| elia IS+ TRT | slight to severe |
| elia M TRT | mild to profound |
| elia S TRT | slight to severe |
| prado CIC TRT | slight to moderate severe |
| prado IS TRT | slight to moderate severe |
| prado IS+ TRT | slight to moderate severe |
| prado M TRT | mild to profound |
| prado S TRT | slight to severe |
| vico CIC TRT | slight to moderate severe |
| vico IS TRT | slight to moderate severe |
| vico IS+ TRT | slight to severe |
| vico M TRT | mild to profound |
| vico S TRT | slight to severe |
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Vasant Dasika -S 2013.11.19 16:56:53 -05'00'
Page 2 of 2