Who can help prepare an FDA 510(k) submission like AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT

Q: Who is the manufacturer of AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT?

Audifon-USA, Inc. filed the 510(k) submission for AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT (K130514).

Q: What is the FDA product code for AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT?

KLW. It is classified under 21 CFR 874.3400 as a Class 2 device in the Ear, Nose, Throat panel.

Q: What is the regulatory pathway for AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT?

510(k) clearance (submission type: Abbreviated).

Q: What are the predicate devices for AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT?

audifon switch 8 TRT (K091552).

K130514 · Audifon-USA, Inc. · KLW · Nov 21, 2013 · Ear, Nose, Throat

Device Facts

Record ID	K130514
Device Name	AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT
Applicant	Audifon-USA, Inc.
Product Code	KLW · Ear, Nose, Throat
Decision Date	Nov 21, 2013
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 874.3400
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Digital hearing aids with integrated tinnitus noise generators; designed for Tinnitus Retraining Therapy (TRT). Devices process acoustic input to provide amplification for hearing loss and generate broadband noise for tinnitus masking/distraction. Operated by patients; fitted by hearing healthcare professionals using audifit software and HI-PRO programming interface. Features up to four programmable noise programs; adjustable noise shape (low/high-cut filters) and output levels. Housed in standard In-the-ear (CIC, IS, IS+) or behind-the-ear (S, S+, M, X) form factors. Output levels limited to <80 dB SPL for TRT and <85 dBA per OSHA guidelines; software includes warnings for high-level settings. Benefits include improved hearing and tinnitus management through combined amplification and masking.

Clinical Evidence

Bench testing only. Performance verified per ANSI S3.22-2009 standards. Non-clinical tests demonstrate equivalent acoustic characteristics, frequency range, and safety profile compared to the predicate device.

Technological Characteristics

Digital hearing aid and noise generator; programmable via HI-PRO and audifit software. Form factors: CIC, IS, IS+, M, S, S+, X. Power: 1.4V zinc-air batteries (sizes 10, 312, 13, 675). Connectivity: Wired programming interface. Standards: ANSI S3.22-2009. Features: 4-program capability, adjustable low/high-cut filters, programmable output levels.

Indications for Use

Indicated for adults with chronic persistent tinnitus who also require hearing amplification for slight to profound hearing loss. Contraindicated for use without consultation from a licensed hearing healthcare professional or audiologist trained in rehabilitation therapy.

Regulatory Classification

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.

Special Controls

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.

Predicate Devices

audifon switch 8 TRT (K091552)

Related Devices

K091552 — SWITCH TRT · Audifon GmbH & Co. KG · Aug 12, 2009
K171243 — audifon Tinnitus-Module · Audiofon USA, Inc. · Oct 19, 2017
K130417 — AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S · Audifon-USA, Inc. · Sep 12, 2013
K123450 — PHONAK TINNITUS BALANCE · Phonak, LLC · Feb 11, 2013
K130937 — WAVE 2G, SOUL · Hansaton Akustik GmbH · Jan 3, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ KB0514 #### 5 510(k) Summary - 1. Applicant's Name and Address: audifon USA Inc. 403 Chairman Ct., Suite 1 Debary, Florida 32713 PO BOX 531700 USA 2. Contact Person: Jane E Perrone Phone: 386-6688812 3. 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) - 4. Device Common Name / Classification Name: ડ. Product Code: ESD, KLW - 6. Classification of Device: Class I for hearing aid Class II for tinnitus masker - 7. Establishment Registration Number: 3005384855 NOV 2 1 2013 {1}------------------------------------------------ audifon GmbH & Co. KG Werner-von-Siemens.Str. 2 D-99625 Kölleda Germany 9. 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): K130514 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

AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT

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AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT

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