(256 days)
No reference devices were used in this submission.
No
The description focuses on traditional signal processing and pre-defined settings, with no mention of AI or ML terms or capabilities.
Yes
The device aids hearing loss, which is a condition that impairs the normal functioning of a bodily system.
No
The ADHEAR system is described as a non-invasive bone conduction hearing device intended to treat patients with conductive hearing loss or single-sided deafness. Its function is to transmit sound to the inner ear, acting as a hearing aid, rather than to diagnose a condition.
No
The device description explicitly lists multiple hardware components (audio processor, adhesive adapters, headband, etc.) that are necessary for the system to function. While it contains software, it is not solely software.
Based on the provided information, the ADHEAR system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- ADHEAR System Function: The ADHEAR system is a hearing device that works by transmitting vibrations through the bone to the inner ear. It directly interacts with the patient's body to improve hearing, rather than analyzing a biological sample.
- Intended Use: The intended use is to treat hearing loss, not to diagnose or monitor a condition through the analysis of biological specimens.
- Device Description: The description details components like microphones, processors, and adhesives, all related to sound transmission and physical attachment, not sample analysis.
- Performance Studies: The performance studies focus on biocompatibility, electrical safety, mechanical testing, and software validation – all relevant to a medical device that interacts with the body, but not typical for IVD performance evaluation (which would involve metrics like sensitivity, specificity, etc., related to analyzing samples).
Therefore, the ADHEAR system falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADHEAR system is intended to treat patients of all ages with conductive hearing loss or single-sided deafness via bone conduction. The ADHEAR system is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband or an adhesive adapter that is placed behind the auricle.
Indications:
· Unilateral or bilateral conductive hearing loss, either chronic or temporary.
The pure tone average bone-conduction hearing threshold (measured at 0.5. 1. 2, and 3 kHz) should be better than or equal to 25 dB HL.
· Single-sided deafness (i.e. unilateral profound sensorineural deafness) with normal hearing on the contralateral side. Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL
Product codes
LXB
Device Description
The ADHEAR system includes a bone conduction audio processor that can be retained on the head with an adhesive adapter or by the headband situated over the mastoid behind the auricle. The ADHEAR system is intended to be used during waking hours. While the adhesive adapter is attached to the skin for 3 to 7 days and then replaced, the audio processor is removed at night. Both the audio processor and the adhesive adapter are necessary components for the system to work. Together the components work as one system to deliver vibrations to the mastoid bone in order to conductively transmit sound to the inner ear for patients with conductive hearing loss or single sided deafness via bone conduction.
The ADHEAR system consists of an adhesive adapter sitting behind the auricle and an audio processor mounted on the attachment. The audio processor contains microphones and signal processing technology as well as a battery. It detects, processes, amplifies and finally transmits sound to the adhesive adapter which transmits vibrations to the mastoid which conducts sounds to the inner ear. The audio processor is equipped with a push button that allows the user to switch between 4 pre-defined settings. A colour sleeve is provided for pediatric use. It features a tamper-proof battery door and dampens potential drops of the processor unit.
The ADHEAR system contains the following components:
- . ADHEAR Audio Processor (model 701)
- Package of ADHEAR Adhesive Adapters
- . ADHEAR Positioning Tool
- ADHEAR Headband
- . Retention clip
- ADHEAR Sleeves
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mastoid, behind the auricle.
Indicated Patient Age Range
all ages
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination.
BIOCOMPATIBILITY TESTING
The performed biocompatibility evaluation concludes that all identified biological risks have been adequately addressed for the ADHEAR System and its accessories according to ISO 10993-1:2009/AC:2010 and the FDA ISO 10993-1 guidance (FDA-2013-D-0350). The performed evaluation provides objective evidence to support the conclusion that the ADHEAR System and its accessories can be considered biocompatible for its intended use.
ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY (EMCL)
Electrical safety, EMC and EMI testing were conducted on the ADHEAR System. The ADHEAR system complies with the applicable sections of the following standards: IEC 60601-1:2005 +A1:2012, IEC 60601-1-11:2015, IEC 60601-1-6:2010 +A1:2013, IEC 62366:2007 +A1:2014, IEC 60601-1-2:2014, and ANSI C63.19:2011.
MECHANICAL AND OTHER TESTING
Bench testing was successfully performed on the ADHEAR system in respect to the defined design specification requirements such as: Frequency range, OFL90, Maximum gain, Total harmonic distortion (THD), Equivalent input noise (EIN), Operating voltage, Current consumption, DAI connection, Signal processing features, Equivalent output noise (EON), Coupling distortion, Basic safety (general, EMC, usability, home healthcare environment), Removal force, Processor unit outer dimensions, Processor unit weight, Processor unit colors, Adhesive adapter colors, Batter door (battery size), Vibrator suspension, Tamper proof battery door, safety line, Push button operating force, Device marking, Drop test, Light exposure, Substance resistance, Power supply stability, Corrosion resistance, Change Battery, Switch device on/off, Adjust volume, change program, Change adhesive adapter, Place/Remove processor unit onto/from adhesive adapter, Push button longevity, DAI connector cycles, Battery door opening/closing cycles, and Protection during shipping
The collective results of the non-clinical testing demonstrate that the ADHEAR System meets the established specifications to ensure consistent and safe performance for its intended use.
SOFTWARE VERIFICATION AND VALIDATION TESTING
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern, since failures or latent flaws in the (optional) software are unlikely to result in any harm to the patient or operator.
CLINICAL TESTING
No clinical testing was needed to support the safety, performance, and substantial equivalence of the ADHEAR System to the predicate devices. All devices are bone conduction hearing aids and all aspects to ensure consistent and safe performance can be shown through non-clinical bench testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3302 Bone-conduction hearing aid.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
April 27, 2018
MED-EL Elektromedizinische Geraete GmbH Elizabeth Gfoeller Corporate Director, Regulatory Affairs Fuerstenweg 77a Innsbruck, AT 6020 Tirol
Re: K172460
Trade/Device Name: ADHEAR System Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: LXB Dated: March 23, 2018 Received: March 30, 2018
Dear Elizabeth Gfoeller:
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.
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
1
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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Eric A. Mann -S
for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172460
Device Name ADHEAR System
Indications for Use (Describe)
The ADHEAR system is intended to treat patients of all ages with conductive hearing loss or single-sided deafness via bone conduction. The ADHEAR system is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband or an adhesive adapter that is placed behind the auricle.
Indications:
· Unilateral or bilateral conductive hearing loss, either chronic or temporary.
The pure tone average bone-conduction hearing threshold (measured at 0.5. 1. 2, and 3 kHz) should be better than or equal to 25 dB HL.
· Single-sided deafness (i.e. unilateral profound sensorineural deafness) with normal hearing on the contralateral side. Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 201 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 201 Subpart C) |
| X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K172460
510(K) Summary
l. SUBMITTER
Applicant:
MED-EL Elektromedizinische Geräte GmbH Fuerstenweg 77a 6020 Innsbruck AUSTRIA Phone: +43 577 88 5614 FAX: +43 577 88 5690
Contact Person:
Elizabeth Gfoeller Corporate Director, Regulatory Affairs MED-EL Elektromedizinische Geräte GmbH Fuerstenweg 77a 6020 Innsbruck AUSTRIA Phone: +43 577 88 5614 FAX: +43 577 88 5690
Date Prepared: March 23, 2018
II. DEVICE
Trade Name: ADHEAR System
Generic/Common Name: Bone Conduction Hearing Prosthesis
Classification: 21 CFR§874.3300, Hearing Aid
Product Code: LXB, Hearing Aid, Bone Conduction
PREDICATE DEVICES III.
- Contact Mini, audifon USA Inc. (K121793) Primary Predicate ●
- . BAHA 5, Cochlear Americas (K142907) Secondary Predicate
No reference devices were used in this submission.
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Image /page/4/Picture/0 description: The image shows the logo for MED-EL, a company that specializes in hearing implants. The logo is in red and features the company name in bold, sans-serif font. A stylized, circular graphic is placed between the "D" and "E" in "MED-EL", adding a unique visual element to the logo.
IV. Device Description
The ADHEAR system includes a bone conduction audio processor that can be retained on the head with an adhesive adapter or by the headband situated over the mastoid behind the auricle. The ADHEAR system is intended to be used during waking hours. While the adhesive adapter is attached to the skin for 3 to 7 days and then replaced, the audio processor is removed at night. Both the audio processor and the adhesive adapter are necessary components for the system to work. Together the components work as one system to deliver vibrations to the mastoid bone in order to conductively transmit sound to the inner ear for patients with conductive hearing loss or single sided deafness via bone conduction.
The ADHEAR system consists of an adhesive adapter sitting behind the auricle and an audio processor mounted on the attachment. The audio processor contains microphones and signal processing technology as well as a battery. It detects, processes, amplifies and finally transmits sound to the adhesive adapter which transmits vibrations to the mastoid which conducts sounds to the inner ear. The audio processor is equipped with a push button that allows the user to switch between 4 pre-defined settings. A colour sleeve is provided for pediatric use. It features a tamper-proof battery door and dampens potential drops of the processor unit.
The ADHEAR system contains the following components:
- . ADHEAR Audio Processor (model 701)
- Package of ADHEAR Adhesive Adapters
- . ADHEAR Positioning Tool
- ADHEAR Headband
- . Retention clip
- ADHEAR Sleeves
V. Indications for Use
The ADHEAR system is intended to treat patients of all ages with conductive hearing loss or single-sided deafness via bone conduction. The ADHEAR system is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband or an adhesive adapter that is placed behind the auricle.
Indications:
- Unilateral or bilateral conductive hearing loss, either chronic or temporary. . The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 25 dB HL.
- Single-sided deafness (i.e. unilateral profound sensorineural deafness) with normal hearing ● on the contralateral side.
Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL
VI. Comparison of Technological Characteristics with The Predicate Device
The ADHEAR System and the predicate devices are bone conduction devices intended to provide hearing improvement via bone conduction. They do so by inducing vibration using the same operating principle of receiving, and transferring the sound via the bone of the skull to the inner ear of a unilaterally or bilaterally hearing impaired person.
At a high level the subject and predicate devices are based on the same technological elements:
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Image /page/5/Picture/0 description: The image shows the logo for MED-EL, a medical device company specializing in hearing implants. The logo is in red and features the company name in bold, sans-serif font. The "O" in MED-EL is replaced by a stylized graphic of a cochlea, which is a spiral-shaped part of the inner ear. The logo is simple, modern, and easily recognizable.
- -Audio processing unit with an electromagnetic transducer, generating vibration audible via bone conduction
- -Coupling of the transducer via an elastic band pressing against the skull bone
- -Battery powered using zinc-air batteries
- -Digital audio signal processing to achieve acoustic amplification
- -User controls
- -Configurable via software
- -Possibility to connect audio sources and ALDs (Assistive Listening Devices)
The following technological differences exist between the subject and predicate devices:
- -Single-unit audio processing unit with snap coupling (identical to BAHA 5 but different to contact mini)
- -Adhesive coupling option from the transducer to the skull bone
- -No coupling option to a surgically implanted abutment (as found in the BAHA 5 predicate only)
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
BIOCOMPATIBILITY TESTING
The performed biocompatibility evaluation concludes that all identified biological risks have been adequately addressed for the ADHEAR System and its accessories according to ISO 10993-1:2009/AC:2010 and the FDA ISO 10993-1 guidance (FDA-2013-D-0350). The performed evaluation provides objective evidence to support the conclusion that the ADHEAR System and its accessories can be considered biocompatible for its intended use.
ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY (EMCL
Electrical safety, EMC and EMI testing were conducted on the ADHEAR System. The ADHEAR system complies with the applicable sections of the following standards: IEC 60601-1:2005 +A1:2012, IEC 60601-1-11:2015, IEC 60601-1-6:2010 +A1:2013, IEC 62366:2007 +A1:2014, IEC 60601-1-2:2014, and ANSI C63.19:2011.
MECHANICAL AND OTHER TESTING
Bench testing was successfully performed on the ADHEAR system in respect to the defined design specification requirements such as: Frequency range, OFL90, Maximum gain, Total harmonic distortion (THD), Equivalent input noise (EIN), Operating voltage, Current consumption, DAI connection, Signal processing features, Equivalent output noise (EON), Coupling distortion, Basic safety (general, EMC, usability, home healthcare environment), Removal force, Processor unit outer dimensions, Processor unit weight, Processor unit colors, Adhesive adapter colors, Batter door (battery size), Vibrator suspension, Tamper proof battery door, safety line, Push button operating force, Device marking, Drop test, Light exposure, Substance resistance, Power supply stability, Corrosion resistance, Change Battery, Switch device on/off, Adjust volume, change program, Change adhesive adapter, Place/Remove processor unit onto/from adhesive adapter, Push button longevity, DAI connector cycles, Battery door opening/closing cycles, and Protection during shipping
The collective results of the non-clinical testing demonstrate that the ADHEAR System meets the established specifications to ensure consistent and safe performance for its intended use.
6
SOFTWARE VERIFICATION AND VALIDATION TESTING
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern, since failures or latent flaws in the (optional) software are unlikely to result in any harm to the patient or operator.
clinical TESTING
No clinical testing was needed to support the safety, performance, and substantial equivalence of the ADHEAR System to the predicate devices. All devices are bone conduction hearing aids and all aspects to ensure consistent and safe performance can be shown through non-clinical bench testing.
VIII. CONCLUSION
The non-clinical data provided support the safety of the device and the hardware verification and validation demonstrate that the ADHEAR System should perform as intended in the specified use conditions. The performance data has confirmed that the ADHEAR System is at least as safe and effective as the predicate devices, the Contact Mini and BAHA 5, and that the ADHEAR System is substantially equivalent to the predicate devices.