AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON
Device Facts
| Record ID | K121793 |
|---|---|
| Device Name | AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON |
| Applicant | Audifon-USA, Inc. |
| Product Code | LXB · Ear, Nose, Throat |
| Decision Date | Nov 1, 2012 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 874.3302 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
Bone conduction hearing aids by BHM-Tech are wearable sound-amplifying devices intended to compensate impairments in personal hearing. The fundamental operating principle is to receive, amplify, and transfer sound via the skin and the bone of the skull to the inner ear of a hearing impaired person. The amplification suits the needs of a mild to a moderate hearing loss. They require individual fitting in performance executed by a hearing aid professional.
Device Story
Digital bone conduction hearing aids (AN-Evo1, contact star evo1, contact mini, apollon) designed to compensate for hearing impairment. Devices receive sound via built-in microphone or induction coil; amplify signal using digital programmable amplifier; transmit vibrations to mastoid or skull via bone vibrator unit. Apollon model also supports air conduction and auxiliary input (TV, MP3, radio). Devices are worn on head (headbands, circlets, eyeglasses, or caps). Fitting performed by audiologist/ENT using BHMFit2 software and HIPRO-Programming Box. Output allows user to perceive sound as nerve impulses, bypassing outer/middle ear. Benefits include improved hearing for patients with mild-to-moderate loss.
Clinical Evidence
Bench testing only. Performance data measured according to DIN IEC 118-9; 1987, including maximum output, maximum gain, HFA-OSPL90, telephone coil sensitivity, equivalent input noise, battery current, and battery life.
Technological Characteristics
Digital programmable bone conduction hearing aids. Materials: medical-grade plastics. Power: battery-operated (Type 675 or 2 AA). Connectivity: induction coil, direct audio input (apollon). Features: volume control, mode switch, digital amplifier. Fitting: BHMFit2 software via HIPRO-Programming Box.
Indications for Use
Indicated for individuals with mild to moderate hearing loss. Target populations: AN-Evo1, contact star evo1, and apollon for adults and children (≥ 12 years); contact mini for adults and children (≥ 8 months).
Regulatory Classification
Identification
A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.
Predicate Devices
Submission Summary (Full Text)
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K121793
NOV
1 2012
# 1. 510(k) Summary
In accordance with 21 CFR 807.92
Applicant's Name and Address: audifon USA, Inc 403 Chairman Court, Suite 1 Debary, FL 32713 U.S.A.
Establishment Registration Number 3005384855 .
Contact Person:
Jane Perrone Phone 1 800 776 0222 Fax 1 386 753 9564 E-mail: jane.perrone@audifon-usa.com
An Evo1...................(bone conduction hearing aid) contact star evo1 ..... (bone conduction hearing aid) contact mini ............ (bone conduction hearing aid) apollon ................... (bone conduction hearing aid)
Date of submission:
Proprietary Name:
Device Common Name
Product Code
Hearing Aid, Bone Conduction
LXB
06/13/2012
Classification of Device
Class: Il Panel: Ear, Nose and Throat Regulation Number: 874 3300
Address of Manufacturing Site
BHM-Tech Produktionsgesellschaft mbH Grafenschachen 242 A-7423 Grafenschachen Austria
Predicate Device
K935701 Starkey Laboratories Inc. VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
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Indications for use: Bone conduction hearing aids by BHM-Tech are wearable soundamplifying devices intended to compensate impairments in personal hearing. The fundamental operating principle is to receive, amplify, and transfer sound via the skin and the bone of the skull to the inner ear of a hearing impaired person. The amplification suits the needs of a mild to a moderate hearing loss. They require individual fitting in performance executed by a hearing aid professional.
The target populations for the devices are as follows:
| AN-Evo1 | adults and children (≥ 12 years) |
|-------------------|----------------------------------|
| contact star evo1 | adults and children (≥ 12 years) |
| contact mini | adults and children (≥ 8 months) |
| apollon | adults and children (≥ 12 years) |
The apollon is a device where it is capable of utilizing either air or bone conduction.
#### Description of Devices
### AN-Evo1
Different to the more common air conduction hearing devices, with digital bone conducted hearing aids AN-Evo1 the sound is produced in a small vibrator and transmitted by direct contact to the mastoid. From here the sound is transmitted via the skull to the inner ear and transformed directly into nerve impulses.
The AN-Evo1 is a hearing aid battery powered, programmable, digital, bone conduction hearing aid which can be mounted onto different aid front-models. For mounting, extension tips and aidfronts with different mechanical dimensions (lengths of extension tips, size of aid-fronts) are available. The AN-Evo1 is also available in different colors (black, brown and anthracite). It can be used monaural or binaural. For monaural, the hearing aid has one active temple and one none-active temple (dummy-temple). For binaural, the hearing aid has two active temples.
The AN-Evo1 includes a digital programmable amplifier and a bone vibrator unit, which are connected directly in one housing. The bone vibrator of the device is held against the head and is driven electrically by the amplifier to transmit the amplified sound as vibrations to the underneath bones of the skull. It also has a built in microphone for picking up sound and a built in induction coil for picking up magnetic fields from induction loop systems. For selecting the operating mode, a three position mode switch is used. The positions are O, OFF, T. Telecoil (induction coil) and M. Microphone. A Volume Control wheel is used to adjust the output power of the device.
The AN-Evo1 is programmable via the HIPRO-Programming Box and BHMFit2 Fittingsoftware. The fitting will only be conducted by an audiologist, a hearing aid specialist or ENT.
### contact star evo1
Different to traditional air conduction hearing devices, by using bone conduction hearing aids contact star-evo1 the sound is produced in a broadband miniature vibration receiver and transmitted by direct skin contact to the mastoid, the area of the temple bone behind the ear. From here it is transmitted through the skull to the inner ear, where it is transformed into nerve impulses.
The contact star evo1 is a hearing aid battery powered, programmable, digital, bone conduction hearing aid which can be mounted onto different aid front-models. For mounting, extension tips
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and aid-fronts with different mechanical dimensions (lengths of extension tips, size of aid-fronts) are available. The contact star evo1 is also available in different colors (black, brown and anthracite).
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It can be used monaural or binaural. For monaural, the hearing aid has one active temple and one none-active temple (dummy-temple). For binaural, the hearing aid has two active temples.
The contact star evo1 includes a high performance digital programmable amplifier and a bone vibrator unit, which are connected directly in one housing. The bone vibrator of the device is held against the head and is driven electrically by the amplifier to transmit the amplified sound as vibrations to the underneath bones of the skull. It also has a built in microphone for picking up sound and a built in induction coil for picking up magnetic fields from induction loop systems. For selecting the operating mode, a three position mode switch is used. The positions are O..OFF, T.Telecoil (induction coil) and M..Microphone. A Volume Control wheel is used to adjust the output power of the device.
The contact star evo1 is programmable via the HIPRO-Programming Box and BHMFit2 programming software. The fitting will only be conducted by an audiologist, a hearing aid specialist or ENT.
### contact mini
The contact mini is a digital bone conduction hearing aid. Sound is transmitted directly through the bones of the skull to the cochlea, bypassing the outer and middle ear.
Contact mini consists of two interconnected units. An amplifier module and an bone vibrator. The amplifier module and the bone vibrator are connected through a wire cable. The amplifier module amplifies the sound and the bone vibrator converts them into vibrations. The bone vibrator has direct contact with the skin. The amplified sound moves through the bones of the inner ear, where it is directly converted into a neural stimulus.
The contact mini is a hearing aid battery powered, programmable, digital, bone conduction hearing aid which can be mounted onto different wearing such as headband, circlets and baseball caps. The contact mini is also available in different colors (black, blue and red).
It can be used monaural or binaural. For monaural, the hearing aid use one active device and one bone vibrator. For binaural, the hearing aid uses two active devices and two bone vibrators.
The contact mini includes a high performance digital programmable amplifier. The amplifier module is completely self-contained and has also a built in microphone for picking up sound. A Volume Control trimmer is used to adjust the output power of the device.
The contact mini is programmable via the HIPRO-Programming Box and BHMFit2 programming software. The fitting will only be conducted by an audiologist, a hearing aid specialist or ENT.
#### apollon
The apollon is also a bone conduction hearing aid. Unlike conventional hearing aids which depend upon acoustic coupling through air, the apollon is based on bone conduction technology. Sound is transmitted directly through the bones of the cochlea, bypassing the outer and middle ear.
The apollon consists of a bone vibrator unit, a shirt pocket sized amplifier module and a wire cable for connecting the bone vibrator with the amplifier module. The bone vibrator is a
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convenient sized unit that is held against the head and is driven electrically to transmit the amplified sound as vibrations to the underneath bones of the skull.
The amplifier module connects the bone vibrator through the wire cable and usually would be carried in the users pocket. The amplifier module is completely self-contained and is battery powered. It also has a built in microphone for picking up sound and a built in induction coil for picking up magnetic fields from induction loop systems. As an added feature an auxiliary 3.5mm input jack allows the user to connect the apollon directly to TV, MP3 players, portable radios or even telephones without any additional adaptors. For selecting the operating mode, a four position mode switch is used. The positions are O..OFF, T..telecoil (induction coil), MT..microphone & telecoil (induction coil) and M..microphone. A Volume Control is used to adjust the output power of the device.
Also, the possibility of a connection between via the DAI (Direct Audio Input) is available. A red LED (Light Emitting Diode) is used for optical low battery warning.
The apollon is equipped with an high performance digital programmable amplifier system which can be adjusted via the BHMFit2 Programming software. The fitting will only be conducted by an audiologist, an hearing aid specialist or ENT.
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# Comparison Tables
| | AN-Evo1 | | Viennatone AN - Fidelity F228 | |
|-------------------------|-----------------------------------------------------------------------------------------------------|-----------------|-----------------------------------------------------------------------------------------------------|--------------------|
| Intended Use | Hearing Aid, Bone Conduction | | Hearing Aid, Bone Conduction | |
| Indications For<br>Use | For mild to moderate hearing losses | | For most severe hearing loss | |
| Target<br>Population | adults and children (>= 12 years) | | adults and children | |
| Materials | Medical Grade plastics | | Medical Grade plastics | |
| | Circuit type: | Digital | Circuit type: | Analog |
| | Programmable: | Yes | Programmable: | No |
| | Channels: | Two | Channels: | One |
| | Volume control: | Yes | Volume control: | Yes |
| | Mode switch: | Yes | Mode switch: | Yes |
| Operation / | Direct Audio Input: | No | Direct Audio Input: | No |
| Mechanism | Induction Coil: | Yes | Induction Coil: | Yes |
| | Low Battery Indication: | Yes | Low Battery Indication: | No |
| | Trimmer: | Yes | Trimmer: | Yes |
| | Program Switch Tones: | Yes | Program Switch Tones: | No |
| | Output-Limitation: | Yes, MPO | Output-Limitation: | Yes, Peak Clipping |
| | Different Colors: | Yes | Different Colors: | No |
| | Maximum Output: | 117 dBOFL | Maximum Output | 114 dBOFL |
| Technical Data | Maximum Gain: | 48 dB | Maximum Gain | 46 dB |
| Measured | HFA-OSPL90: | 113 dBOFL | HFA-OSPL90: | 109 dBOFL |
| according DIN | Telephone coil sensitivity: | 94dB | Telephone coil sensitivity: | 90dB |
| IEC 118-9; 1987 | Equivalent input noise:<br>Battery current | 26 dB<br>1,2 mA | Equivalent input noise:<br>Battery current | 30 dB<br>2,2 mA |
| | Battery life time | ~475 hours | Battery life time | ~260 hours |
| Where Used | May be used anywhere | | May be used anywhere | |
| Physical<br>Description | Bone Conduction Aid which can be<br>mounted with special Extension tips on<br>different Eyeglasses. | | Bone Conduction Aid which can be<br>mounted with special Extension tips on<br>different Eyeglasses. | |
| Power Source | Battery type 675 | | Battery type 675 | |
## Abbreviations:
| MPO. | Maximum Peak Output |
|-------|-----------------------------|
| dBOFL | deci Bel Output Force Level |
The AN-Evo1 is substantially equivalent to the Viennatone AN – Fidelity F228 (K935701). The AN-Evo1 differs from the Viennatone AN – Fidelity F228, in that the AN-Evo1 is a digital product with programmable characteristics, which increases the flexibility of fitting the device (Two
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programmable channels are available, Low battery indication, Program switch tones). The AN-Evo1 is also available in different colors.
These differences are in the region of the production tolerances and do not affect the safety and effectiveness of the device when used as labeled.
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| | contact star evo1 | | Viennatone AS - Fidelity F229 | |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------|
| Intended Use | Hearing Aid, Bone Conduction | | Hearing Aid, Bone Conduction | |
| Indications For Use | For mild to moderate hearing losses | | For moderate to severe hearing losses | |
| Target Population | adults and children (>= 12 years) | | adults and children | |
| Materials | Medical Grade plastics | | Medical Grade plastics | |
| Operation / Mechanism | Circuit type: | Digital | Circuit type: | Analog |
| | Programmable: | Yes | Programmable: | No |
| | Channels: | Two | Channels: | One |
| | Volume control: | Yes | Volume control: | Yes |
| | Mode switch: | Yes | Mode switch: | Yes |
| | Direct Audio Input: | No | Direct Audio Input: | No |
| | Induction Coil: | Yes | Induction Coil: | Yes |
| | Low Battery Indication: | Yes | Low Battery Indication: | No |
| | Trimmer: | No | Trimmer: | No |
| | Program Switch Tones: | Yes | Program Switch Tones: | No |
| | Output-Limitation: | Yes, MPO | Output-Limitation: | No |
| | Different Colors: | Yes | Different Colors: | Yes |
| Technical Data<br>Measured<br>according DIN<br>IEC 118-9; 1987 | Maximum Output: | 110 dBOFL | Maximum Output | 109 dBOFL |
| | Maximum Gain: | 50 dB | Maximum Gain | 42 dB |
| | HFA-OSPL90: | 108 dBOFL | HFA-OSPL90: | 105 dBOFL |
| | Telephone coil sensitivity:<br>Equivalent input noise:<br>Battery current<br>Battery life time | 95dB<br>24 dB<br>1,2 mA<br>~500 hours | Telephone coil sensitivity:<br>Equivalent input noise:<br>Battery current<br>Battery life time | 88dB<br>28 dB<br>2,15 mA<br>~280 hours |
| Where Used | May be used anywhere | | May be used anywhere | |
| Physical<br>Description | Bone Conduction Aid which can be<br>mounted with special Extension tips on<br>different Eyeglasses. | | Bone Conduction Aid which can be<br>mounted with special Extension tips on<br>different Eyeglasses. | |
| Power Source | Battery type 675 | | Battery type 675 | |
Abbreviations:
MPO Maximum Peak Qutput dBOFL deci Bel Qutput Eorce Level
The contact star evo1 is substantially equivalent to the Viennatone AS – Fidelity F229 (K935701). The contact star evo1 differs from the Viennatone AS – Fidelity F229, in that the contact star evo1 is a digital product with programmable characteristics, which increases the flexibility of fitting the device (Two programmable channels are available, Low battery indication, Program switch tones, Output-Limitation).
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These differences are in the region of the production tolerances and do not affect the safety and effectiveness of the device when used as labeled.
. .
・
:
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| | contact mini | Viennatone AS - Fidelity F229 | | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Intended Use | Hearing Aid, Bone Conduction | Hearing Aid, Bone Conduction | | |
| Indications For Use | For mild to moderate hearing losses | For moderate to severe hearing losses | | |
| Target Population | adults and children (>= 8 months) | adults and children | | |
| Materials | Medical Grade plastics | Medical Grade plastics | | |
| Operation / Mechanism | Circuit type: Digital<br>Programmable: Yes<br>Channels: Two<br>Volume control: Yes<br>Mode switch: No<br>Direct Audio Input: No<br>Induction Coil: No<br>Low Battery Indication: Yes<br>Trimmer: No<br>Program Switch Tones: Yes<br>Output-Limitation: Yes, MPO<br>Different Colors: Yes<br>Battery Compartment lock Yes | Circuit type: Analog<br>Programmable: No<br>Channels: One<br>Volume control: Yes<br>Mode switch: Yes<br>Direct Audio Input: No<br>Induction Coil: Yes<br>Low Battery Indication: No<br>Trimmer: No<br>Program Switch Tones: No<br>Output-Limitation: No<br>Different Colors: Yes<br>Battery Compartment lock No | | |
| | Technical Data<br>Measured<br>according DIN<br>IEC 118-9; 1987 | Maximum Output: 112 dBOFL<br>Maximum Gain: 49 dB<br>HFA-OSPL90: 107 dBOFL<br>Equivalent input noise: 22 dB<br>Battery current 1,25 mA<br>Battery life time ~230 hours | Maximum Output 109 dBOFL<br>Maximum Gain 42 dB<br>HFA-OSPL90: 105 dBOFL<br>Equivalent input noise: 28 dB<br>Battery current 2,15 mA<br>Battery life time ~280 hours | |
| | | Where Used | May be used anywhere | May be used anywhere |
| | | Physical Description | Bone Conduction Hearing aid which can<br>be mounted on different wearing<br>systems (Headbands, Circlets) | Bone Conduction Aid which can be<br>mounted with special Extension tips on<br>different Eyeglasses. |
| | | Power Source | Battery type 13 | Battery type 675 |
Abbreviations:
MPO Maximum Peak Qutput dBOFL deci Bel Qutput Force Level
The contact mini is substantially equivalent to the Viennatone AS – Fidelity F229 (K935701). The contact mini differs from the Viennatone AS - Fidelity F229, in that the contact mini is a digital product with programmable characteristics, which increases the flexibility of fitting the device (Two programmable channels are available, Low battery indication, Program switch tones, Output-Limitation, Battery Compartment lock). These differences are in the region of the
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production tolerances and do not affect the safety and effectiveness of the device when used as labeled. ﭘ
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| | apollon | | Viennatone AN - Fidelity F228 | |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------|-----------------------------------------------------------------------------------------------------|--------------------|
| Intended Use | Hearing Aid, Bone Conduction | | Hearing Aid, Bone Conduction | |
| Indications For<br>Use | For mild to moderate hearing losses | | For most severe hearing loss | |
| Target<br>Population | adults and children ( >= 12 years) | | adults and children | |
| Materials | Medical Grade plastics | | Medical Grade plastics | |
| | Circuit type: | Digital | Circuit type: | Analog |
| | Programmable: | Yes | Programmable: | No |
| | Channels: | Four | Channels: | One |
| | Volume control: | Yes | Volume control: | Yes |
| | Mode switch: | Yes | Mode switch: | Yes |
| Operation /<br>Mechanism | Direct Audio Input: | Yes | Direct Audio Input: | No |
| | Induction Coil: | Yes | Induction Coil: | Yes |
| | Low Battery Indication: | Yes | Low Battery Indication: | No |
| | Trimmer: | No | Trimmer: | Yes |
| | Program Switch Tones: | Yes | Program Switch Tones: | No |
| | Output-Limitation: | Yes, MPO | Output-Limitation: | Yes, Peak Clipping |
| | Different Colors: | No | Different Colors: | No |
| | Maximum Output: | 125 dBOFL | Maximum Output | 114 dBOFL |
| Technical Data<br>Measured<br>according DIN<br>IEC 118-9; 1987 | Maximum Gain: | 64 dB | Maximum Gain | 46 dB |
| | HFA-OSPL90: | 115 dBOFL | HFA-OSPL90: | 109 dBOFL |
| | Telephone coil sensitivity: | 94dB | Telephone coil sensitivity: | 90dB |
| | Equivalent input noise: | 26 dB | Equivalent input noise: | 30 dB |
| | Battery current | 15,6 mA | Battery current | 2,2 mA |
| | Battery life time | ~160 hours | Battery life time | ~260 hours |
| Where Used | May be used anywhere | | May be used anywhere | |
| Physical<br>Description | Bone Conduction Hearing aid which can<br>be used in combination with an External<br>Bone conductors (mounted on a Circlet) | | Bone Conduction Aid which can be<br>mounted with special Extension tips on<br>different Eyeglasses. | |
| Power Source | 2 AA Batteries | | Battery type 675 | |
Abbreviations:
MPO Maximum Peak Output dBOFL deci Bel Qutput Eorce Level
The apollon is substantially equivalent to the Viennatone AN – Fidelity F228 (K935701). The apollon differs in that it is a device where it is capable of utilizing either air or bone conduction. It is also a digital device which is programmable to the consumers needs by a hearing professional adding to its flexibility in fitting (Four programmable channels are available, Direct Audio Input, Low battery indication, Program switch tones, Output-Limitation). The apollon also uses a
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different power source. These differences do not affect the safety and effectiveness of the device when used as labeled.
## Risks to health
The AN-Evo1, contact star evo1, contact mini and apollon has the SAME intended use and does not raise different questions regarding safety and effectiveness. All patient skin contacting materials are manufactured from biocompatible materials that have been used in other medical devices. A User's Instruction Guide is supplied with each hearing aid.
## Hearing Healthcare Professional Diagnosis
The sale and fitting of the aids will only be conducted through a Hearing Healthcare Professional, such as an audiologist, hearing aid specialist or ENT.
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Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
NOV 1 2012
Audifon-USA, Inc. c/o Ms. Jane E. Perrone VP of U.S. Operations 403 Chairman Ct., Suite 1 DeBary, FL 32713
Re: K121793
Trade/Device Name: An Evo 1, CS Evo 1, Contact Mini, Apollon Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: LXB Dated: September 18, 2012 Received: September 25, 2012
# 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.
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# 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 (OS) 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/ucm115809.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 vours.
Qecken un of
Malvina B. Eydelman, M. Director Division of Ophthalmic. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# KI21792
# 5. Indications for Use Statement
K121793 510(k) Number (if known): Device Name:
AN-Evo1 ......................................................(bone conduction hearing aid) contact star evo1 ............................................................................................................................................................ contact mini ..................................................(bone conduction hearing ald) apollon.......................................................................................................................................................................
Indications for use:
Bone conduction hearing aids by BHM-Tech are wearable sound-amplifying devices intended to compensate impairments in personal hearing. The fundamental operating principle is to receive, amplify, and transfer sound via the skin and the bone of the skull to the inner ear of a hearing Impaired person. The amplification suits the needs of a mild to a moderate hearing loss. They require individual fitting in performance executed by a hearing aid professional.
The target populations for the devices are as follows:
AN-Evo1 contact star evo1 contact mini apollon
adults and children (≥ 12 years) adults and children (≥ 12 years) adults and children (≥ 8 months) adults and children (≥ 12 years)
The apollon is a device where it is capable of utilizing either air or bone conduction.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ch. S
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of 1
510(k) Number K121793
Section 5 - Page 1 of 1
