(267 days)
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.
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).
This 510(k) Premarket Notification is for a set of Tinnitus Retraining Therapy (TRT) devices (various models under audifon arriva, elia, prado, and vico brands). The submission claims substantial equivalence to a predicate device, the audifon switch 8 TRT (K091552).
The core of the study is a comparison of technical specifications and performance against a predicate device, as opposed to a clinical trial with acceptance criteria for a new device's performance. The acceptance criteria are implicit in demonstrating that the new devices are "as safe, as effective, and perform as well as the predicate device."
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This study does not define explicit performance acceptance criteria in terms of sensitivity, specificity, accuracy, or similar metrics for diagnostic devices. Instead, the acceptance criteria are based on demonstrating equivalence in technical specifications and functionality to the predicate device. The "reported device performance" section will therefore compare the key characteristics of the new devices to the predicate.
| Feature/Acceptance Criterion (Implicit) | Predicate Device (audifon switch 8 TRT) Performance | New Devices (audifon arriva, elia, prado, vico TRT models) Performance | Meets Criterion? |
|---|---|---|---|
| Indications for Use (Adult population, chronic tinnitus, amplification, TRT protocol) | Adult population, chronic tinnitus, amplification (mild to moderate hearing loss), TRT program. | Adult population, chronic tinnitus, amplification (slight to profound hearing loss), TRT protocol. | Yes, with an expanded range for hearing loss amplification (slight to profound vs. mild to moderate). This expansion is acceptable as it addresses a broader patient need. |
| Operation/Mechanism (Broadband noise, digital, programmable, 4 noises) | Uses broadband noise; digital; programmable; 4 noises. | Uses broadband noise; digital; programmable; 4 noises. | Yes |
| Adjustable white-noise | Yes | Yes | Yes |
| Programmable noise level | Yes | Yes | Yes |
| Adjustable Low Battery Indicator | Yes | Yes | Yes |
| Programmable Program Switch Tones | Yes | Yes | Yes |
| Where Used (May be used anywhere) | May be used anywhere | May be used anywhere | Yes |
| Physical Description (Housing) | Standard receiver-in-the-ear instrument housing | Standard In-the-ear (CIC, IS, IS+) or Behind-the-ear (S, S+, M, X) instrument housing. | Yes, devices are similar in style (ITE or BTE) to the predicate. |
| Maximum Output (White noise SPL) | 100 dB SPL | arriva: 70-74 dB SPLelia/prado: 71-72 dB SPLvico: 107-113 dB SPL | Yes. The submission argues that for TRT only low sound levels below 80 dB SPL are needed, and that the lower maximum output of many models has no influence on effectiveness. For vico models exceeding predicate, OSHA limits are noted in context of hearing loss. |
| Frequency Range | 200 - 6000 Hz | 200 - 8000 Hz | Yes, the new devices offer a wider frequency range, which is demonstrably "equivalent white noise with the same sound quality" (stated in comparison text). |
| Power Source | Standard 312 zinc air 1.4V battery | Various standard zinc air 1.4V batteries (10, 312, 13, 675). | Yes, uses standard hearing aid batteries. |
| Quality Assurance Standard | ANSI S3.22-2009 | ANSI S3.22-2009 | Yes |
| Similar Acoustic Characteristics | N/A (predicate comparison) | Non-clinical performance data measured according to ANSI S3.22-2009 verify similar effectiveness. | Yes |
| Similar Material | N/A (predicate comparison) | Similar | Yes |
| Similar Intended Use | N/A (predicate comparison) | Similar | Yes |
| Same Targeted Population | N/A (predicate comparison) | Same | Yes |
| Special Controls (21 CFR 874.3400) | Applied for predicate | Identically applied | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The submission relies on non-clinical performance data measured according to official standards (ANSI S3.22-2009) to demonstrate equivalence. This is not a test set of patient data. The data provenance is from the device manufacturer, and it is a retrospective comparison against published standards and the predicate device's specifications. No specific "sample size" in terms of patients or independent measurements is provided, other than the implication of standard compliance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on non-clinical performance data measured against engineering standards (ANSI S3.22-2009) and direct comparison of specifications to a predicate device, rather than expert-established ground truth from clinical data.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" in the context of clinical data requiring adjudication. The assessment is based on technical specifications and compliance with recognized standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC comparative effectiveness study was not done. The submission is based on technical and functional equivalence to a predicate device, not on clinical effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the devices are "algorithm only" in the sense that they are hardware that generates sounds, the evaluation itself is not about an "algorithm's diagnostic performance." Instead, it's a standalone technical evaluation of the device's acoustic characteristics and features against industry standards and a predicate device.
7. The Type of Ground Truth Used
The "ground truth" used is defined by:
- Official standards: Specifically, ANSI S3.22-2009 for the proper functioning of hearing aids.
- Predicate device specifications: The audifon switch 8 TRT (K091552) serves as the benchmark for comparison of features and performance characteristics.
- Regulatory requirements: Compliance with "special controls" as defined in 21 CFR 874.3400 for tinnitus maskers and OSHA noise exposure guidelines (29CFR 1910.95) for maximum output levels.
8. The Sample Size for the Training Set
Not applicable. These are not AI/ML devices that require a training set in the conventional sense. The "development" of these devices would involve engineering design and testing, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model for this type of device submission.
{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 TRTaudifon arriva IS TRTaudifon arriva IS+ TRTaudifon arriva M TRTaudifon arriva S TRTaudifon arriva S+ TRTaudifon arriva X TRT | switch 8 TRT | |
|---|---|---|
| Indications ForUse | The combined devices are intended for the adultpopulation suffering from a chronic persistentringing in the ears (Tinnitus), who also need ordesire amplification. The amplification suits theneeds of a slight to a profound hearing loss. Theproducts may also be used for masking Tinnitusas part of a Tinnitus Retraining Therapy (TRT)protocol and should be utilized only inconsultation with a licensed hearing healthcareprofessional, who is trained in subsequentrehabilitation therapy, or a qualified audiologist. | The device is addressed to the adult populationwith a chronic persistent ringing in the ears(Tinnitus), who also need or desire amplification.The amplification suits the needs of a mild to amoderate hearing loss. It may be used formasking tinnitus as part of tinnitus managementprogram that is prescribed by a licensed hearinghealthcare professional, who is trained insubsequent rehabilitation therapy, or a qualifiedaudiologist. Therefore it generates a broadbandnoise with sufficient bandwidth and intensity andis applied on the ear. |
| Operation /Mechanism | Uses broadband noise; Manages tinnitus throughmasking and distractionCircuit type:DigitalProgrammable:YesAvailable noises:FourVolume control:Yes (M, S, S+ X)Optional (CIC, IS, IS+) | Uses broadband noise; Manages tinnitus throughmasking and distractionCircuit type:DigitalProgrammable:YesAvailable noises:FourVolume control:No |
| white-noise is adjustablenoise level is programmableadjustable Low Battery Indicatorprogrammable Program Switch Tones | white-noise is adjustablenoise level is programmableadjustable Low Battery Indicatorprogrammable Program Switch Tones | |
| Where Used | May be used anywhere | May be used anywhere |
| PhysicalDescription | 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: | |
| MaximumOutput | 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 aidbattery |
| QualityAssuranceStandard | ANSI S3.22-2009 to ensure proper functioning ofHA | ANSI S3.22-2009 to ensure proper functioning ofHA |
.
{5}------------------------------------------------
| audifon elia CIC TRTaudifon elia IS TRTaudifon elia IS+ TRTaudifon elia M TRTaudifon elia S TRT | switch 8 TRT | |
|---|---|---|
| Indications ForUse | The combined devices are intended for the adultpopulation suffering from a chronic persistentringing in the ears (Tinnitus), who also need ordesire amplification. The amplification suits theneeds of a slight to a profound hearing loss. Theproducts may also be used for masking Tinnitusas part of a Tinnitus Retraining Therapy (TRT)protocol and should be utilizedonlyinconsultation with a licensed hearing healthcareprofessional, who is trained in subsequentrehabilitation therapy, or a qualified audiologist. | The device is addressed to the adult populationwith a chronic persistent ringing in the ears(Tinnitus), who also need or desire amplification.The amplification suits the needs of a mild to amoderate hearing loss. It may be used formasking tinnitus as part of tinnitus managementprogram that is prescribed by a licensed hearinghealthcare professional, who is trained insubsequent rehabilitation therapy, or a qualifiedaudiologist. Therefore it generates a broadbandnoise with sufficient bandwidth and intensity andis applied on the ear. |
| Uses broadband noise; Manages tinnitus throughmasking and distraction | Uses broadband noise; Manages tinnitus throughmasking and distraction | |
| Operation /Mechanism | Circuit type:DigitalProgrammable:YesAvailable noises:FourVolume control:Yes (M, S)Optional (IS, IS+)No (CIC) | Circuit type:DigitalProgrammable:YesAvailable noises:FourVolume control:No |
| white-noise is adjustablenoise level is programmableadjustable Low Battery Indicatorprogrammable Program Switch Tones | white-noise is adjustablenoise level is programmableadjustable Low Battery Indicatorprogrammable Program Switch Tones | |
| Where Used | May be used anywhere | May be used anywhere |
| PhysicalDescription | 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 |
| MaximumOutput | 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 aidbattery |
| QualityAssuranceStandard | ANSI S3.22-2009 to ensure proper functioning ofHA | ANSI S3.22-2009 to ensure proper functioning ofHA |
| audifon prado CIC TRTaudifon prado IS TRTaudifon prado IS+ TRTaudifon prado M TRTaudifon prado S TRT | switch 8 TRT | |
| Indications ForUse | The combined devices are intended for the adultpopulation suffering from a chronic persistentringing in the ears (Tinnitus), who also need ordesire amplification. The amplification suits theneeds of a slight to a profound hearing loss. Theproducts may also be used for masking Tinnitusas part of a Tinnitus Retraining Therapy (TRT)protocol and should be utilized only inconsultation with a licensed hearing healthcareprofessional, who is trained in subsequentrehabilitation therapy, or a qualified audiologist. | The device is addressed to the adult populationwith a chronic persistent ringing in the ears(Tinnitus), who also need or desire amplification.The amplification suits the needs of a mild to amoderate hearing loss. It may be used formasking tinnitus as part of tinnitus managementprogram that is prescribed by a licensed hearinghealthcare professional, who is trained insubsequent rehabilitation therapy, or a qualifiedaudiologist. Therefore it generates a broadbandnoise with sufficient bandwidth and intensity andis applied on the ear. |
| Uses broadband noise; Manages tinnitus throughmasking and distraction | Uses broadband noise; Manages tinnitus throughmasking and distraction | |
| Operation /Mechanism | Circuit type:DigitalProgrammable:YesAvailable noises:FourVolume control:Yes (M, S)Optional (IS, IS+)No (CIC) | Circuit type:DigitalProgrammable:YesAvailable noises:FourVolume control:No |
| white-noise is adjustablenoise level is programmableadjustable Low Battery Indicatorprogrammable Program Switch Tones | white-noise is adjustablenoise level is programmableadjustable Low Battery Indicatorprogrammable Program Switch Tones | |
| Where Used | May be used anywhere | May be used anywhere |
| PhysicalDescription | 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: |
| OutputCharacteristics | 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 aidbattery |
| QualityAssuranceStandard | ANSI S3.22-2009 to ensure proper functioning ofHA | ANSI S3.22-2009 to ensure proper functioning ofHA |
| audifon vico CIC TRTaudifon vico IS TRTaudifon vico IS+ TRTaudifon vico M TRTaudifon vico S TRT | switch 8 TRT | |
| Indications ForUse | The combined devices are intended for the adultpopulation suffering from a chronic persistentringing in the ears (Tinnitus), who also need ordesire amplification. The amplification suits theneeds of a slight to a porfound hearing loss. Theproducts may also be used for masking Tinnitusas part of a Tinnitus Retraining Therapy (TRT)protocol and should be utilized only inconsultation with a licensed hearing healthcareprofessional, who is trained in subsequentrehabilitation therapy, or a qualified audiologist. | The device is addressed to the adult populationwith a chronic persistent ringing in the ears(Tinnitus), who also need or desire amplification.The amplification suits the needs of a mild to amoderate hearing loss. It may be used formasking tinnitus as part of tinnitus managementprogram that is prescribed by a licensed hearinghealthcare professional, who is trained insubsequent rehabilitation therapy, or a qualifiedaudiologist. Therefore it generates a broadbandnoise with sufficient bandwidth and intensity andis applied on the ear. |
| Operation /Mechanism | Uses broadband noise; Manages tinnitus throughmasking and distraction | Uses broadband noise; Manages tinnitus throughmasking and distraction |
| Circuit type:DigitalProgrammable:YesAvailable noises:FourVolume control:Yes (M, S)Optional (CIC, IS, IS+)white-noise is adjustablenoise level is programmableadjustable Low Battery Indicatorprogrammable Program Switch Tones | Circuit type:DigitalProgrammable:YesAvailable noises:FourVolume control:Nowhite-noise is adjustablenoise level is programmableadjustable Low Battery Indicatorprogrammable Program Switch Tones | |
| Where Used | May be used anywhere | May be used anywhere |
| PhysicalDescription | 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: | |
| MaximumOutputCharacteristics | 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 aidbattery |
| QualityAssuranceStandard | ANSI S3.22-2009 to ensure proper functioning ofHA | ANSI S3.22-2009 to ensure proper functioning ofHA |
·
{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
§ 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.