· Patients 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 65 dB HL for use with the Ponto 5 SuperPower 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 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 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

The Ponto Bone Anchored Hearing System consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant with the abutment is surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound. The sound processor can be connected and disconnected by the user by the snap coupling.

The sound processors are individually adjusted to the patient audiogram and needs via the Genie Medical BAHS fitting software by the Hearing Care Professional (HCP). The HCP connects the sound processors to the computer running the Genie Medical BAHS fitting software through either a wireless connection or a cable.

Ponto 5 SuperPower sound processor is a further development of and substantially equivalent to the primary predicate Ponto 3 SuperPower (K161671) and predicate Ponto 5 Mini (K211640).

As for both predicates, the Ponto 5 SuperPower sound processor is intended for improvement of hearing for patients with conductive or mixed hearing losses, whether unilaterally or bilaterally fitted, or for those with single-sided deafness.

Ponto 5 SuperPower sound processor is indicated for hearing losses up to and including 65 dB HL (BC), same as the primary predicate Ponto 3 SuperPower sound processor.

Ponto 5 SuperPower sound processor includes the same sound processing platform and wireless technology as the predicate Ponto 5 Mini sound processor, enabling the same sound processing features and compatibility options as Ponto 5 Mini.

A minor updated hardware design (electronic and mechanic) is implemented in Ponto 5 SuperPower sound processor as compared to Ponto 3 SuperPower (K161671), to allow for a side neutral design that carries the same design and look as Ponto 5 Mini (K211640).

The functionality and features of the firmware in Ponto 5 SuperPower are the same as for predicate device Ponto 5 Mini, however updated in a new revision. No functionality or features of the firmware are changed, added or removed by this update.

Other than the minor updates in hardware design and the very minor change to the firmware, the technological characteristics of the Ponto 5 sound processors remain unchanged from the original design (as latest cleared in K161671 for Ponto 3 SuperPower and K211640 for Ponto 5 Mini).

Additional purposes of this 510(k) notice is to include a minor modification to the accessory Genie Medical BAHS fitting software and to include the addition of Softband 5 to the Ponto Bone Anchored Hearing System:

The fitting software is, as part of this 510(k), updated to include compatibility with Ponto 5 SuperPower in addition to Ponto 5 Mini and Ponto 4. No feature or functionality is changed, added or deleted in Genie Medical BAHS 2022.1, when compared to the current version Genie Medical BAHS 2021.2 (cleared together with Ponto 5 Mini in K211640).
-The Softband, previously cleared through K082108 and latest in K161671. consists of a band placed around the wearers head with a connector plate to which the sound processor is attached. The Softband can be used by patients in the pre-operative evaluation phase or as a long-term solution to benefit from the sound processor without having an implant (primarily children). The Softband can be used also bilaterally. The band and the connector plate have been modified for optimal comfort and use.

AI/ML Overview

The provided text describes the regulatory clearance for the Ponto 5 SuperPower sound processor. It clarifies that this device is a modification of previously cleared sound processors, the Ponto 3 SuperPower (K161671) and Ponto 5 Mini (K211640), and asserts substantial equivalence to these predicates. The document focuses on demonstrating that the new device does not raise new safety or effectiveness concerns.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, the primary "acceptance criterion" is proving substantial equivalence to predicate devices, particularly in terms of performance characteristics relevant to hearing aids. The key performance aspect explicitly mentioned and compared is "Maximum Force Output."

Acceptance Criteria (Implied)	Reported Device Performance for Ponto 5 SuperPower
Equivalence of Maximum Force Output	"Maximum Force Output is measured and found comparable for Ponto 5 SuperPower and primary predicate Ponto 3 SuperPower (K161671)."
Software Verification	Performance data includes software verification.
Electroacoustic Verification	Performance data includes electroacoustic verification.
Electrical and Mechanical Safety Evaluation	Performance data includes electrical and mechanical safety evaluation.
Electromagnetic Compatibility (EMC) Evaluation	Performance data includes electromagnetic compatibility (EMC) evaluation.
Documentation of Radio Properties and Performance	Performance data includes documentation of radio properties and performance.
Functional Equivalence of Sound Processing Features	"No functionality or feature is changed, added or removed" compared to Ponto 5 Mini.
Functional Equivalence of Firmware	"No functionality or features of the firmware are changed, added or removed by this update."
Substantial Equivalence (Overall Safety & Effectiveness)	"The performance data confirm that the Ponto 5 SuperPower sound processors are substantially equivalent compared to the primary predicate Ponto 3 SuperPower (K161671) and predicate Ponto 5 Mini (K211640)." "The minor technological differences... raise no new issues of safety or effectiveness."

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

The document does not specify a "test set" in the context of human subjects or a defined dataset with a particular sample size for performance evaluation. Instead, it refers to "performance data" derived from standard engineering and regulatory tests. The provenance of this data (country of origin, retrospective/prospective) is not explicitly stated, but it is implied to be internal testing conducted by the manufacturer for regulatory compliance.

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

This information is not applicable in the context of this document. The device is a medical device (hearing aid), not an AI/ML algorithm that requires expert consensus for ground truth on a test set. The performance evaluation relies on established engineering standards and comparative analysis with predicate devices.

4. Adjudication Method for the Test Set:

This information is not applicable. See point 3.

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

This information is not applicable. The document does not describe an MRMC study comparing human readers with and without AI assistance. The device is a hearing aid, not an AI diagnostic tool that assists human readers in interpreting medical images or data.

6. Standalone (Algorithm Only) Performance:

This information is not applicable. The Ponto 5 SuperPower is a physical hearing aid device with embedded software and hardware for sound processing. Its performance is evaluated as a complete system, not as a standalone algorithm without human interaction.

7. Type of Ground Truth Used:

The "ground truth" here is based on established engineering standards and measurements for hearing aid performance (e.g., IEC 60118-9:2019 for Maximum Force Output) and the performance characteristics of the legally marketed predicate devices. The comparison relies on demonstrating that the new device meets or is comparable to these established standards and predicate performances.

8. Sample Size for the Training Set:

This information is not applicable. The Ponto 5 SuperPower is not an AI/ML device that requires a "training set" in the conventional sense for machine learning model development. Its development and verification involve engineering design, testing, and comparison to existing products and standards.

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

This information is not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. Food & Drug Administration" in blue text.

December 16, 2021

Oticon Medical AB Anja Ravn Regulatory Affairs Manager Datavagen 37B Askim, SE-436 32 Sweden

Re: K213733

Trade/Device Name: Ponto 5 SuperPower Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: LXB, MAH Dated: November 23, 2021 Received: November 26, 2021

Dear Anja Ravn:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213733

Device Name Ponto 5 SuperPower

Indications for Use (Describe)

Ponto 5 SuperPower sound processors are intended for the following patients and indications:

· 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.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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510(k) SUMMARY - K213733

Oticon Medical AB's Ponto Bone Anchored Hearing System

Ponto Sound Processors, Ponto 5 SuperPower

Oticon Medical AB Submitter: Datavägen 37B SE-436 32 Askim Sweden

Phone: +46 31 748 61 00 Facsimile: +46 31 687 756

Contact Person: Anja Ravn

Mobile phone: +45 26774422

December 10, 2021 Date Prepared:

Name of Device: Ponto 5 SuperPower

Common or Usual Name: Ponto Bone Anchored Hearing System

Classification Name: Hearing aid, bone conduction.

Regulatory Class: 21 CFR §874.3300, Class II

Product Code: LXB, MAH

Predicate Devices

Device	510(k) no.	Manufacturer
Ponto 3 SuperPower (Primary)	K161671	Oticon Medical AB
Ponto 5 Mini	K211640	Oticon Medical AB

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Device Description and purpose of the 510(k) notice

The main purpose of this 510(k) notification is to include the Ponto 5 SuperPower sound processor in the Ponto 5 sound processor family, which is part of the Ponto Bone Anchored Hearing System.

Ponto 5 SuperPower sound processor is a further development of and substantially equivalent to the primary predicate Ponto 3 SuperPower (K161671) and predicate Ponto 5 Mini (K211640).

Ponto 5 SuperPower sound processor is indicated for hearing losses up to and including 65 dB HL (BC), same as the primary predicate Ponto 3 SuperPower sound processor.

The functionality and features of the firmware in Ponto 5 SuperPower are the same as for predicate device Ponto 5 Mini, however updated in a new revision.

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No functionality or features of the firmware are changed, added or removed by this update.

The fitting software is, as part of this 510(k), updated to include compatibility with Ponto 5 SuperPower in addition to Ponto 5 Mini and Ponto 4. No feature or functionality is changed, added or deleted in Genie Medical BAHS 2022.1, when compared to the current version Genie Medical BAHS 2021.2 (cleared together with Ponto 5 Mini in K211640).
-The Softband, previously cleared through K082108 and latest in K161671. consists of a band placed around the wearers head with a connector plate to which the sound processor is attached. The Softband can be used by patients in the pre-operative evaluation phase or as a long-term solution to benefit from the sound processor without having an implant (primarily children). The Softband can be used also bilaterally. The band and the connector plate have been modified for optimal comfort and use.

Intended Use / Indications for Use

Intended use

The Ponto Bone Anchored Hearing System is intended for improvement of hearing for patients with conductive or mixed hearing losses, whether unilaterally or bilaterally fitted, or for those with single-sided deafness.

Indications for use

Ponto 5 SuperPower sound processors are intended for the following patients and indications:

. Patients 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 65 dB HL for use with the Ponto 5 SuperPower sound processor.

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. 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 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 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).

Summary of Technological Characteristics

The Ponto 5 SuperPower is a modification of the previously cleared sound processors, primary predicate Ponto 3 SuperPower (K161671) and predicate Ponto 5 Mini (K211640).

The electrical and mechanical design of Ponto 5 SuperPower includes minor modifications to size and shape in comparison to the predicate devices, Ponto 5 Mini and Ponto 3 SuperPower. The vibrator has the same topology as the Ponto 4/Ponto 5 Mini vibrator but is adjusted in size to adapt to needed power level. However, the fundamental electrical and mechanical design remain the same.

As the primary predicate device, Ponto 3 SuperPower, the Ponto 5 SuperPower is powered by a size 675P hearing aid battery (1.4 V) and includes a tamper resistant battery drawer, and local user control of listening volume and program change.

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As the predicate device. Ponto 5 Mini, the Ponto 5 SuperPower incorporates wireless 2.4 GHz Bluetooth® Low Energy connectivity, side-neutral design, and a LED status indicator.

The sound processing platform in Ponto 5 SuperPower sound processor enables the same sound processing features as Ponto 5 Mini (K211640). No functionality or feature is changed, added or removed.

Ponto 5 SuperPower sound processor provides compatibility with the same range of wireless accessories as Ponto 5 Mini (K211640).

Summary of performance data

Performance data for the Ponto 5 SuperPower sound processors is produced using the same well-established methods as for primary predicate Ponto 3 SuperPower (K161671) and predicate Ponto 5 Mini (K211640).

The performance data includes software verification, electroacoustic verification, electrical and mechanical safety evaluation, electromagnetic compatibility (EMC) evaluation, and documentation of radio properties and performance.

Maximum Force Output is measured and found comparable for Ponto 5 SuperPower and primary predicate Ponto 3 SuperPower (K161671) in accordance with IEC 60118-9:2019 Electroacoustics - Hearing aids - Part 9: Methods of measurement of the performance characteristics of bone conduction hearing aids.

The performance data confirm that the Ponto 5 SuperPower sound processors are substantially equivalent compared to the primary predicate Ponto 3 SuperPower (K161671) and predicate Ponto 5 Mini (K211640).

Substantial Equivalence Conclusion

The Ponto 5 SuperPower sound processors have the same intended use as the primary predicate Ponto 3 SuperPower (K161671).

Ponto 5 SuperPower sound processors have similar principles of operations as the Ponto 5 Mini and Ponto 3 SuperPower sound processors. The sound processor is connected via an abutment to an implant placed in the temporal bone behind the ear, and the vibrations from the sound processor are transmitted directly to the inner ear through bone conduction. The implant and abutment are installed by a surgical procedure, and the sound processor can be connected and disconnected bv the user bv the snap coupling.

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As the predecessors, Ponto 5 SuperPower sound processors are individually adjusted to the patient audiogram and needs via the Genie Medical BAHS fitting software by the HCP. The HCP connects the sound processors to the computer running the Genie Medical BAHS fitting software. The sound processors are connected either via cable to Hi-Pro2 or ExpressLink (wired fitting equipment) or wireless using Noahlink (wireless fitting equipment) or the Oticon RemoteCare app.

Genie Medical BAHS 2022.1 and Ponto 5 SuperPower includes the same fitting options as the predicate device, Ponto 5 Mini with Genie Medical BAHS 2021.2 (cleared in K211640).

Comparison table

	Modified device	Primary predicate device	Predicate device
	Ponto 5 SuperPower	Ponto 3 SuperPower	Ponto 5 Mini
		(K161671)	(K211640)
IntendedUse	Improvement of hearing forpatients with conductive andmixed hearing losses, whetherunilaterally or bilaterally fittedor for those with single sideddeafness.	Same as for Ponto 5SuperPower	Same as for Ponto 5SuperPower
Indicationsfor Use	• Patients with conductive ormixed hearing losses, whocan still benefit fromamplification of the sound.The pure tone average(PTA) bone conduction (BC)threshold (measured at 0.5,1, 2 and 3 kHz) of theindicated ear should bebetter than or equal to 65 dBHL.• Bilateral fitting is applicablefor most patients having asymmetrically conductive ormixed hearing loss. Thedifference between the leftand right sides' BCthresholds should be lessthan 10 dB on averagemeasured at 0.5, 1, 2 and 4kHz, or less than 15 dB atindividual frequencies.• Patients who have aprofound sensorineuralhearing loss in one ear andnormal hearing in theopposite ear (i.e. singlesided deafness or "SSD").The pure tone average(PTA) air conduction (AC)threshold of the hearing earshould then be better thanor equal to 20 dB HL(measured at 0.5, 1, 2 and 3	Same as for Ponto 5SuperPower	Same, except that patient'spure tone average (PTA) boneconduction (BC) threshold(measured at 0.5, 1, 2 and 3kHz) of the indicated earshould be better than or equalto 45 dB HL (as opposed tothe 65 dB HL for Ponto 3SuperPower and Ponto 5SuperPower).
	Modified device	Primary predicate device	Predicate device
	Ponto 5 SuperPower	Ponto 3 SuperPower	Ponto 5 Mini
		(K161671)	(K211640)
	• Also indicated for anypatient who is indicated foran air-conductioncontralateral routing ofsignals (AC CROS) hearingaid, but who for somereason cannot or will not usean AC CROS.The placement of a boneanchored implant iscontraindicated for patientbelow the age of 5.The Ponto sound processorsare intended to be used witheither the Ponto implantsystem or with specificcompatible Bahaabutments/implants fromCochlear Bone AnchoredSolutions (BAS) (refer to thePonto labeling for specificcompatible Cochlear models).In addition, selected CochlearBaha sound processors can beused with the Pontoimplant/abutment system (referto the Ponto labeling forcompatible Baha soundprocessor models).
Soundprocessingfeatures	OpenSound Navigator™OpenSound Optimizer™Clear DynamicsTransient Noise ManagementFeedback Shield (LX)64 Processing channelsSpeech Guard LXWind noise managementBattery management systemFitting bandwidth of 10 kHz	FreeFocus (directionalitysystem)Tri-state Noise ReductionInium Sense feedback shield15 sound processing channelsSpeech GuardWind Noise ReductionBattery management systemBinaural ProcessingFitting bandwidth of 10 kHz	Same as for Ponto 5SuperPower
Wirelessfeatures	Receiver and transmitter, 2.4GHz, Bluetooth® Low Energy	Wireless connections toexternal devices through theOticon Medical Streamer(using NFMI 3.84 MHzconnection).	Same as for Ponto 5SuperPower
Couplingfeatures	Material: PEEKSnap coupling outside theabutment	Same as for Ponto 5SuperPower	Same as for Ponto 5SuperPower
SafetyFeatures	• Tamper-resistant batterydrawer• Maximum coupling safetyrelease force	Same as for Ponto 5SuperPower	• Tamper-resistant batterydrawer option included in thesales package• Maximum coupling safetyrelease force
	Modified device	Primary predicate device	Predicate device
	Ponto 5 SuperPower	Ponto 3 SuperPower	Ponto 5 Mini
		(K161671)	(K211640)
Accessories	Oticon Medical accessories:• Head band, test band,softband and SoundConnector• Genie Medical BAHS fittingsoftware, version 2022.1• Skins for personalizationCompatible wireless OticonA/S/SBO Hearing A/Saccessories:• Remote control 3.0• ConnectClip• TV Adapter 3.0• EduMic• Oticon ON app• Oticon RemoteCare app	Oticon Medical accessories:• Head band, test band,softband and SoundConnector• Genie Medical BAHS fittingsoftware, version 2016.1• Skins for personalizationCompatible wireless OticonA/S accessories:• Oticon Medical Streamer	Same as for Ponto 5SuperPower(Compatible with GenieMedical BAHS fitting software,version 2021.2 and 2022.1)
Fittingoptions	Wired fitting:Hi-Pro 2ExpressLinkWireless fitting:Noahlink wirelessOticon RemoteCare app	Wired fitting:Hi-Pro 2ExpressLink	Same as for Ponto 5SuperPower
Features infittingsoftware	16 channel frequencyresponse shapingBC In-situ AudiometryFeedback AnalyzerData LoggingAutomatics (OpenSoundsettings, Transient NoiseReduction settings andSilencer Control)Single-sided deafness fittingmodeSoft band fitting modeWireless connection duringfittingWireless accessories settingtoolVisual and audible indicatorssettingTechnical Measurement toolVerification toolFLogramProgram ManagerSpecial Purpose ProgramsRemoteCare option	10 fitting frequency responseshapingBC In-situ AudiometryFeedback ManagerData LoggingAutomatics (directionalitymode and noise management)Single-sided deafness fittingmodeSoft band fitting modeFitting AssistantWireless accessories settingtool (ConnectLine)Audible indicator settingTechnical Measurement toolVerification toolFLogramProgram Manager	Same as for Ponto 5SuperPower

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Conclusion

The Ponto 5 SuperPower is a modification of the previously cleared sound processors, primary predicate Ponto 3 SuperPower (K161671) and predicate Ponto 5 Mini (K211640).

The fundamental electrical and mechanical design remain similar to the predicate devices, Ponto 3 SuperPower and Ponto 5 Mini. The maximum force output of

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the Ponto 5 SuperPower sound processor is equivalent to that provided by the predicate Ponto 3 SuperPower sound processor.

The minor technological differences between the Ponto 5 SuperPower sound processors and their predicate devices raise no new issues of safety or effectiveness. Using the same methods, the performance data for the Ponto 5 SuperPower sound processors demonstrate that they are as safe and effective as the predicate devices, Ponto 5 Mini and Ponto 3 SuperPower.

Therefore, it is concluded that the Ponto 5 SuperPower sound processors are substantially equivalent to the predicate devices, primary predicate Ponto 3 SuperPower (K161671) and predicate Ponto 5 Mini (K211640).

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.