The Ponto Plus sound processors are intended for improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single sided deafness.

The Ponto Plus and Ponto Plus Power are intended for the following patients and indications:

Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto Plus sound processor, 55 dB HL for use with the Ponto Plus Power sound processor.
Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 4 kHz, or less than 15 dB at individual frequencies.
Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The placement of a bone anchored implant is contraindicated for patient below the age of 5.

The Ponto Plus and Ponto Plus Power sound processors are intended to be used with either the Ponto implant system or with specific compatible BAHA abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto Plus labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/abutment system (refer to the Ponto labeling for compatible Baha sound processor models).

Device Description

Ponto Plus and Ponto Plus Power are modifications of the previously cleared Ponto Pro (K090996) and Ponto Pro Power (K103594) and represent the two latest sound processor models in the Ponto bone anchored hearing system. A bone anchored hearing system consists of a sound processor connected to an implant with a skin penetrating abutment. The implant is surgically anchored in the skull bone behind the ear. Vibrations generated by the sound processor are transmitted via the implant directly through the skull bone to the cochlea as bone conduction sound processor has a coupling so that it can be easily connected to and disconnected from the abutment by the user. Alternatively, it can be connected to head band accessories, to function as a conventional bone conductor. Using a computer based fitting system the sound processor can be adjusted to the patient's individual hearing requirements. The Ponto Plus family utilizes wireless technology and can receive audio signals from external sources when used together with an optional accessory, Ponto Streamer, from Oticon A/S. Ponto Streamer can also be used as a remote control to adjust the volume of the sound processor, or to change the listening program. The Ponto Plus family is intended to be used with either the Ponto implant system or with specific compatible BAHA abutments/implants from Cochlear Bone Anchored Solutions (BAS). The Ponto Plus sound processors include the same sound processing features as the currently marketed models but they have also been complemented with an updated sound processing feature for feedback cancellation, the Inium feedback shield. Also the transducer design in Ponto Plus sound processors has been optimized resulting in higher maximum output in the mid to high frequency range.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Ponto Plus and Ponto Plus Power devices:

Based on the provided document, the submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo safety and effectiveness through extensive clinical trials. Therefore, the "study that proves the device meets the acceptance criteria" is primarily an equivalency assessment grounded in technical testing and comparison to existing, legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly lay out a table of "acceptance criteria" in the sense of specific performance thresholds for a clinical study endpoint. Instead, the acceptance criteria are implicitly defined by the performance of the predicate devices and relevant standards. The "reported device performance" refers to the Ponto Plus family's ability to meet these established benchmarks.

Criterion Type	Acceptance Criteria (Implied)	Reported Device Performance (Ponto Plus / Ponto Plus Power)
Intended Use/Indications Equivalence	To have the same intended use and indications for use as predicate devices (Ponto Pro K090996, Ponto Pro Power K103594, and legally marketed Oticon A/S air conduction hearing aids for wireless technology).	"The Ponto Plus sound processors have the same intended use and indications, as well as principles of operation as their predicate devices." (Identical Indications for Use are listed for Ponto Plus/Ponto Plus Power as for Ponto Pro/Ponto Pro Power). Wireless technology is stated to be "the same as the wireless technology used in the legally marketed, class II 510(k)-exempt Oticon A/S air conduction hearing aids".
Technological Equivalence (Sound Processing)	To include sound processing features comparable to the predicate Ponto Pro/Pro Power (15 channels, multiband adaptive directionality, Speech Guard, Tri-state noise reduction, Wind noise reduction) and to incorporate an updated feedback cancellation feature equivalent to that in predicate Oticon A/S air conduction hearing aids.	Includes all predicate features + "Inium feedback shield" (same as in legal marketed Class II, 510(k)-exempt Oticon A/S air conduction hearing aids).
Technological Equivalence (Transducer Output)	To demonstrate performance comparable or improved over the predicate Ponto Pro/Pro Power, specifically regarding maximum output in the mid to high-frequency range.	"transducer design...optimized resulting in higher maximum output in the mid to high frequency range." "Performance of the more powerful transducer has been verified."
Wireless Functionality	To incorporate wireless technology for receiving audio signals from external sources via an accessory (Ponto Streamer) with comparable functionality and range to the wireless technology in predicate Oticon A/S air conduction hearing aids. The device should function as a receiver only, without binaural communication or wireless fitting.	"The Ponto Plus family utilizes wireless technology and can receive audio signals from external sources when used together with an optional accessory, Ponto Streamer." "Ponto Streamer can also be used as a remote control..." "Wireless range between the Ponto Streamer and the Ponto Plus sound processors" was verified. Wireless technology is "the same as...Oticon A/S air conduction hearing aids" except Ponto Plus functions as receivers only, preventing binaural communication and wireless fitting.
Electromagnetic Compatibility (EMC)	To not emit excessive amounts of electromagnetic energy (EMC emissions) and to operate as intended without performance degradation in the presence of an electromagnetic disturbance (EMC immunity), in accordance with IEC 60601-1-2.	"tested to (1) not emit excessive amounts of electromagnetic energy (EMC emissions); (2) operate as intended without performance degradation in the presence of an electromagnetic disturbance (EMC immunity)." Complies with IEC 60601-1-2.
Electroacoustical Performance	To demonstrate expected performance across various parameters including battery voltage and current consumption, frequency range, Peak OFLs at 90, 60 and 50 dB SPL, total harmonic distortion, and equivalent input noise.	"Electroacoustical verification has been conducted including tests for battery voltage and current consumption, frequency range, Peak OFLs at 90, 60 and 50 dB SPL, total harmonic distortion and equivalent input noise." "In all instances, the Ponto Plus sound processors functioned as intended and the performance observed was as expected."
Compatibility	To be demonstrable as compatible with the Ponto implant system, specific compatible BAHA abutments/implants from Cochlear BAS, and for selected Cochlear Baha sound processors to be compatible with the Ponto implant/abutment system.	"intended to be used with either the Ponto implant system or with specific compatible BAHA abutments/implants from Cochlear Bone Anchored Solutions (BAS)." Also, "selected Cochlear Baha sound processors can be used with the Ponto implant/abutment system."
Safety Features	To include safety features comparable to the predicate devices, specifically a tamper-proof battery door and a maximum coupling safety release force around 31 N.	"Tamper proof battery door" and "Maximum coupling safety release force around 31 N" are listed as identical to the predicate.
Compliance with Standards	To comply with relevant international and national standards, including ISO 13485, 21 CFR Part 820, 93/42/EEC, ISO 14971, IEC 60601-1-2, IEC 60118-13, EN ISO 10993-1, ISO 15223, EN 1041.	The device is stated to comply with all listed standards, which are identical to those of the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes functional testing and firmware validation rather than clinical studies with "test sets" in the typical sense of patient cohorts.

Sample Size for Test Set: Not applicable in the context of clinical patient data. The "test set" here refers to the device itself undergoing various technical and performance tests. The testing focuses on the device's physical and electronic characteristics.
Data Provenance: The testing was conducted by the manufacturer, Oticon Medical AB, in Sweden. It is retrospective in the sense that it evaluates the manufactured device against pre-established technical specifications and predicate device performance. There is no mention of prospective patient data collection for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The ground truth for this type of submission is established by engineering and quality control specifications, compliance with recognized industry standards, and documented performance of the predicate devices. It does not involve expert clinical review of test data in the way a diagnostic AI product might.

4. Adjudication Method for the Test Set:

Not applicable. Technical testing is verified against specifications, not through a consensus of human adjudicators.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (hearing aid) that directly treats a condition (hearing loss) by amplifying sound, rather than providing diagnostic information that human readers would interpret. Its effectiveness is assessed through its performance characteristics and equivalence to predicate devices, not through a comparative study of human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The device is a physical hearing aid that works in conjunction with the human user's auditory system. There is no "algorithm only" performance that stands alone from its mechanical and electronic function within a human use case. The "algorithms" mentioned (e.g., feedback cancellation) are integrated functionalities of the device. The technical tests conducted are essentially a "standalone" evaluation of the device's physical performance characteristics.

7. Type of Ground Truth Used:

The ground truth used for this submission is:

Technical Specifications: Performance parameters (e.g., frequency range, output levels, power consumption) are measured against predefined engineering specifications.
International Standards: Compliance with recognized electrical safety, EMC, and quality management standards (e.g., IEC 60601-1-2, ISO 13485).
Predicate Device Performance: The established, legally marketed performance and safety profiles of the Ponto Pro/Pro Power and specific Oticon A/S air conduction hearing aids serve as benchmarks for demonstrating equivalence.

8. Sample Size for the Training Set:

Not applicable. This device is a hardware product with integrated signal processing, not a machine learning or AI model in the sense of requiring a "training set" of data to learn from. The design and optimization of its sound processing features (like the Inium feedback shield) would have involved extensive engineering development and testing, but not a "training set" in the context of computational learning.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" for an AI model. The "ground truth" for the device's design and functionality comes from auditory science, psychoacoustics, electrical engineering principles, and clinical knowledge of hearing loss and its amplification.

Summary

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DEC 9 2013

510(k) SUMMARY

Ponto Plus and Ponto Plus Power

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Submitter name:	Oticon Medical AB
Address:	Ekonomiv. 2SE-436 33 AskimSweden

Phone: +46 31 748 6100 Facsimile: +46 31 687 756

Contact Person: Satu Hjärtstam Mobile phone: +46 735 44 98 13

Date Prepared: September 2, 2013

Name of Device and Name/Address of Manufacturer

Ponto Plus and Ponto Plus Power

Oticon Medical AB Ekonomiv. 2 SE-436 33 Askim Sweden

Common or Usual Name: Ponto bone anchored hearing system

Classification Name: Hearing aid, bone conduction

Classification Regulation: 21 C.F.R. §874.3300 (Product codes LXB, MAH)

Predicate Devices

Device	510(k) no.	Manufacturer
Ponto bone anchored hearing system	K090996 (Ponto Pro)	Oticon Medical AB
Ponto bone anchored hearing system	K103594 (Ponto Pro Power)	Oticon Medical AB
Air conduction hearing aid	Exempt from 510k.	Oticon A/S

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Intended Use / Indications for Use

Intended use

The Ponto Plus sound processors are intended for improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single sided deafness.

Indications for use

The Ponto Plus and Ponto Plus Power are intended for the following patients and indications:

Patient with conductive or mixed hearing losses, who can still benefit from amplification . of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto Plus sound processor, 55 dB HL for use with the Ponto Plus Power sound processor.
. Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 4 kHz, or less than 15 dB at individual frequencies.
. Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
. Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The placement of a bone anchored implant is contraindicated for patient below the age of 5.

Technological Characteristics

Ponto Plus and Ponto Plus Power are modifications of the previously cleared Ponto Pro (K090996) and Ponto Pro Power (K103594) and represent the two latest sound processor models in the Ponto bone anchored hearing system. (Hereinafter referred to as the Ponto Plus sound processors or as the Ponto Plus family when referring to both models and Ponto Plus and Ponto Plus Power when referring to the 2 different models.) A bone anchored hearing system consists of a sound processor connected to an implant with a skin penetrating abutment. The implant is surgically anchored in the skull bone behind the ear. Vibrations generated by the sound processor are transmitted via the implant directly through the skull bone to the cochlea as bone conduction sound processor has a coupling so that it can be easily connected to and disconnected from the abutment by the user. Alternatively, it can be connected to head band accessories, to function as a conventional bone conductor. Using a computer based fitting system the sound processor can be adjusted to the patient's individual hearing requirements.

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. The Ponto Plus family utilizes wireless technology and can receive audio signals from external sources when used together with an optional accessory, Ponto Streamer, from Oticon A/S. Ponto Streamer can also be used as a remote control to adjust the volume of the sound processor, or to change the listening program. The Ponto Plus family is intended to be used with either the Ponto implant system or with specific compatible BAHA abutments/implants from Cochlear Bone Anchored Solutions (BAS).

The Ponto Plus sound processors include the same sound processing features as the currently marketed models but they have also been complemented with an updated sound processing feature for feedback cancellation, the Inium feedback shield. The Inium feedback shield is the same as included in the predicate Oticon A/S air conduction hearing aids legally marketed as class II, 510(k)-exempt devices. Also the transducer design in Ponto Plus sound processors has been optimized resulting in higher maximum output in the mid to high frequency range.

This submission also includes addition of an alternative surgical approach to the Surgical manual for the previously cleared Ponto implant system part of the Ponto bone anchored hearing system. The new surgical technique, referred to as tissue preservation surgery, is a minimally invasive technique that requires no or limited soft tissue removal.

Discussion of testing

Testing of the Ponto Plus family includes functional testing and firmware validation. The sound processors have been tested to (1) not emit excessive amounts of electromagnetic energy (EMC emissions); (2) operate as intended without performance degradation in the presence of an electromagnetic disturbance (EMC immunity). Also electroacoustical verification has been conducted including tests for battery voltage and current consumption, frequency range, Peak OFLs at 90, 60 and 50 dB SPL, total harmonic distortion and equivalent input noise. Performance of the more powerful transducer has been verified, as well as the functionality of the updated feedback cancellation system. Furthermore, tests were conducted to verify the compatibility and the wireless range between the Ponto Streamer and the Ponto Plus sound processors. The above mentioned tests verify that the Ponto Plus and the Ponto Plus Power are equivalent to the Ponto Pro and the Ponto Pro Power, respectively, and that the wireless communication via the Ponto Streamer is functionally equivalent to the same of the predicate Oticon A/S air conduction hearing aids legally marketed as class II, 510(k)-exempt devices. In all instances, the Ponto Plus sound processors functioned as intended and the performance observed was as expected. Hence we have come to the conclusion that further testing will not raise new issues of safety and efficacy.

Substantial Equivalence

The Ponto Plus and the Ponto Plus Power are as safe and effective as the Ponto Pro and the Ponto Pro Power sound processors. The Ponto Plus sound processors have the same intended use and indications, as well as principles of operation as their predicate devices. The wireless technology in the Ponto Plus sound processors is the same as the wireless technology used in the legally marketed, class II 510(k)-exempt Oticon A/S air conduction hearing aids except that the Ponto Plus sound processors function as receivers only, thus

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they do not allow for binaural communication and wireless fitting. The minor technological differences between the Ponto Plus sound processors and their predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Ponto Plus sound processors are as safe and effective as Ponto Pro and Ponto Pro Power sound processors. Thus, the Ponto Plus and Ponto Plus Power are substantially equivalent.

Comparison table

	Ponto Plus /Ponto Plus Power(No K-number yet)	Ponto Pro (K090996) /Ponto Pro Power (K103594)	Oticon air conductivehearing aid with wirelesstechnology(legally marketed, class II510(k)-exempt)
Intended Use	Improvement of hearing forpatients with conductive and mixedhearing losses, bilateral fitting andsingle sided deafness.	Same	To amplify and transmit soundto the ear and herebycompensate for impairedhearing. Indicated for hearinglosses within mild-to- severe-to-profound range.
Sound processingfeatures	•15 sound processing channels• Multiband adaptive directionality• Speech Guard• Tri-state noise reduction• Wind noise reduction• Inium feedback shield	• 15 sound processing channels•Multiband adaptive directionality• Speech Guard• Tri-state noise reduction• Wind noise reduction• Dynamic feedback cancellation	•15 sound processing channels•Multiband adaptivedirectionality• Speech Guard• Tri-state noise reduction• Wind noise reduction• Inium feedback shield+ other features
Fitting features	•10 channel frequency responseshaping• BC In-situ Audiometry• Feedback Manager• Data Logging• Technical Measurement tool• Verification tool• Ponto Streamer Settings tool	• 10 channel frequency responseshaping• BC In-situ Audiometry• Feedback Manager• Data Logging	• 10 channel frequencyresponse shaping• Feedback Manager• Data Logging• Technical Measurement tool• Verification tool• Streamer Pro Settings tool+ other features
Wireless	Yes	No	Yes
Coupling	• Material: PEEK• Snap coupling outside theabutment	Same	N/A
Accessories	• Head band, test band andsoftband• Genie Medical fitting software• Xpress• Skins for personalization• Ponto Streamer	• Head band, test band andsoftband• Genie Medical fitting software• Xpress• Telecoil, Audio adapter, FM	Various accessories, includingGenie fitting software andOticon Streamer Pro
Safety Features	• Tamper proof battery door• Maximum coupling safety releaseforce around 31 N	Same	N/A
Standards withwhich the DeviceComplies	• ISO 13485:2012• 21 CFR Part 820• 93/42/EEC• ISO 14971:2007• IEC 60601-1-2• IEC 60118-13• EN ISO 10993-1:2009• ISO 15223:2012• EN 1041:2008	• ISO 13485:2012• 21 CFR Part 820• 93/42/EEC• ISO 14971:2007• IEC 60601-1-2• EN 60118-13:2005• EN ISO 10993-1:2004• ISO 15223• EN 1041:2008	N/A

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or profiles, with flowing lines suggesting movement or connection.

December 9, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6 Silver Spring, MD 20993-0002

Otiocon Medical AB % Ms. Satu Hjärtstam Quality Assurance and Regulatory Affairs Specialist Ekonomivägen 2 Askim, Sweden SE-436 33

Re: K132775

Trade/Device Name: Ponto Plus and Ponto PlusPower Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing aid, bone conduction Regulatory Class: Class II Product Code: LXB Dated: September 11, 2013 Received: September 13, 2013

Dear Ms. Hjärtstam:

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. Iisting 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

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Page 2 - Ms. Satu Hjärtstam

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/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

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Indications for Use

510(k) Number (if known): K 132775

Device Name: Ponto Plus and Ponto Plus Power

Indications for use:

The Ponto Plus and Ponto Plus Power are intended for the following patients and indications:

Patient with conductive or mixed hearing losses, who can still benefit from amplification of the . sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto Plus sound processor, 55 dB HL for use with the Ponto Plus Power sound processor.
. Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 4 kHz, or less than 15 dB at individual frequencies.
Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the . opposite ear (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
. Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The placement of a bone anchored implant is contraindicated for patient below the age of 5,

Prescription Use _ x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sageev George -S 2013.12.09 12:25:25 -05'00'

Page 1 of 1

Regulation Number and Section

§ 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.