(75 days)
Exempt from 510(k)
No
The document describes a sound processor with firmware modifications and compatibility updates, but there is no mention of AI or ML technology being incorporated into the device's functionality or processing. The performance studies focus on electroacoustic properties and safety, not on the evaluation of AI/ML algorithms.
Yes
Explanation: The device is a hearing system intended to amplify sound for individuals with hearing loss, which is a therapeutic function.
No
Explanation: The device is described as a "sound processor" intended for patients with hearing loss, transmitting sound through bone conduction to the cochlea to improve hearing. It is a therapy device, not a diagnostic one.
No
The device description explicitly states that the system consists of an external sound processor unit and an implant with a skin penetrating abutment, which are hardware components. While there are software/firmware modifications, the core device is a hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Ponto 5 Mini sound processor is a bone-anchored hearing system. It works by transmitting sound vibrations directly through the skull bone to the cochlea to improve hearing for individuals with specific types of hearing loss.
- Intended Use: The intended use is to provide amplification of sound for patients with conductive, mixed, or single-sided hearing loss.
- Mechanism of Action: The device physically processes and transmits sound, it does not analyze biological samples.
The description clearly indicates that this is a hearing aid system that works through bone conduction, not a device that performs diagnostic tests on biological specimens.
N/A
Intended Use / Indications for Use
Ponto 5 Mini 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 45 dB HL for use with the Ponto 5 Mini 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).
Product codes
LXB, MAH
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 surqically 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 snap coupling.
Ponto 5 Mini is a further development of the Ponto 4, cleared in K190540.The main difference between Ponto 5 Mini and Ponto 4 is a modification to the firmware in the Ponto 5 sound processors to additionally include the sound processing feature OpenSound™ Optimizer and an added compatibility with Oticon RemoteCare App from SBO Hearing A/S. Other than the minor changes to the firmware and compatibility, the technological characteristics of the Ponto 5 sound processors remain unchanged from the original design (most recently cleared in K190540).
Additionally, minor modifications to the accessory Genie Medical BAHS fitting software are made (e.g., added compatibility with Oticon RemoteCare App, addition of special purpose programs, and inclusion of DSL BC).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, specifically the bone behind the ear (temporal bone) for implant placement.
Indicated Patient Age Range
The placement of a bone anchored implant is contraindicated for patient below the age of 5.
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)
Performance data for the Ponto 5 Mini sound processors is produced using the same methods and acceptance criteria as for Ponto 4.
Electroacoustic verification includes Maximum output responses, Output for full-on gain at 50 dB SPL and 60 dB SPL, Equivalent input noise level, Total harmonic distortion, Frequency range, Battery voltage, Current Consumption, Battery lifetime, IRIL (input related interference level) and Processing delay. The results were according to requirements and equivalent to the performance of the predicate device, Ponto 4.
Ponto 5 Mini sound processors have been evaluated and found to have the same electrical and mechanical safety, electromagnetic compatibility (EMC), and radio properties and performance, that was established for the predicate. Ponto 4.
The above-mentioned performance data confirm that the Ponto 5 Mini sound processors are as safe and efficient as the Ponto 4 sound processors. In all instances, the Ponto 5 Mini sound processors functioned as intended and the performance observed was as expected. It is therefore concluded that further testing will not raise new issues of safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Exempt from 510(k)
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
August 10, 2021
Oticon Medical AB Anja Ravn Regulatory Affairs Manager Datavagen 37B Askim. SE-436 32 Sweden
Re: K211640
Trade/Device Name: Ponto 5 Mini Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: LXB, MAH Dated: July 9, 2021 Received: July 12, 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
1
801): medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (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-advice-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,
for Shu-Chen Peng Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
510(k) Number (if known) K211640 Device Name
Ponto 5 Mini
Indications for Use (Describe)
Ponto 5 Mini 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 45 dB HL for use with the Ponto 5 Mini 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).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (7/17)
3
510(k) SUMMARY K211640
Oticon Medical AB's Ponto Bone Anchored Hearing System
Ponto Sound Processors, Ponto 5 Mini
Submitter: Oticon Medical AB 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
Date Prepared: August 8, 2021
Name of Device: Ponto 5 Mini
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 |
|---|---|---|
| Predicate device: Ponto 4 | K190540 | Oticon Medical AB |
| Reference device: Oticon Opn STM air conduction wireless hearing aid | Exempt from 510(k) | Oticon A/S |
4
Device Description and purpose of the 510(k) notice
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 surqically 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 snap coupling.
Ponto 5 Mini is a further development of the Ponto 4, cleared in K190540.The main difference between Ponto 5 Mini and Ponto 4 is a modification to the firmware in the Ponto 5 sound processors to additionally include the sound processing feature OpenSound™ Optimizer and an added compatibility with Oticon RemoteCare App from SBO Hearing A/S. Other than the minor changes to the firmware and compatibility, the technological characteristics of the Ponto 5 sound processors remain unchanged from the original design (most recently cleared in K190540).
Additionally, minor modifications to the accessory Genie Medical BAHS fitting software are made (e.g., added compatibility with Oticon RemoteCare App, addition of special purpose programs, and inclusion of DSL BC).
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 fitted, or for those with single-sided deafness.
Indications for use
Ponto 5 Mini 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 45 dB HL for use with the Ponto 5 Mini 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.
5
- 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 svstem (refer to the Ponto labeling for compatible Baha sound processor models).
Summary of Technological Characteristics
The Ponto 5 Mini is a modification of the previously cleared sound processor, Ponto 4 (K190540), and represents the latest sound processor model in the Ponto Bone Anchored Hearing System.
The electrical and mechanical design of Ponto 5 Mini is unchanged from the predicate device, Ponto 4.
As the predicate device, Ponto 5 Mini is powered by a size 312 hearing aid battery (1.4 V) and incorporates wireless 2.4 GHz Bluetooth Low Energy connectivity, an exchangeable battery drawer for tamper resistant option, side-neutral design, and LED status indicator.
The firmware in Ponto 5 Mini sound processor includes an addition of the sound processing feature OpenSound™ Optimizer to the feedback management system. This sound processing feature introduces no new risk. Also, it does not alter or contributes to existing risks.
Further, Ponto 5 Mini sound processor adds to the list of compatible wireless accessories by including compatibility with the Oticon RemoteCare App from SBO Hearing A/S. This provides the option for remote appointments with the Hearing Care Professional (HCP). This possibility introduces no new risk, nor does it alter or contributes to existing risks.
6
Discussion of performance data
Performance data for the Ponto 5 Mini sound processors is produced using the same methods and acceptance criteria as for Ponto 4.
Electroacoustic verification includes Maximum output responses, Output for full-on gain at 50 dB SPL and 60 dB SPL, Equivalent input noise level, Total harmonic distortion, Frequency range, Battery voltage, Current Consumption, Battery lifetime, IRIL (input related interference level) and Processing delay. The results were according to requirements and equivalent to the performance of the predicate device, Ponto 4.
Ponto 5 Mini sound processors have been evaluated and found to have the same electrical and mechanical safety, electromagnetic compatibility (EMC), and radio properties and performance, that was established for the predicate. Ponto 4.
The above-mentioned performance data confirm that the Ponto 5 Mini sound processors are as safe and efficient as the Ponto 4 sound processors. In all instances, the Ponto 5 Mini sound processors functioned as intended and the performance observed was as expected. It is therefore concluded that further testing will not raise new issues of safety and efficacy.
Substantial Equivalence Conclusion
The Ponto 5 Mini sound processors have the same intended use as the Ponto 4 sound processor in K190540.
Ponto 5 Mini sound processors have the similar principles of operations as the Ponto 4 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 by the user by the snap coupling.
The sound processor is 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 through either a wireless connection to a Noahlink (wireless fitting) or a cable and a Hi-Pro 2 or ExpressLink (wired fitting).
Genie Medical BAHS 2021.2 and Ponto 5 Mini includes the same fitting options for the HCP as the predicate device, Ponto 4 with Genie Medical BAHS 2019.1 (cleared in K190540), as well as an option for remote wireless fitting through compatibility with Oticon RemoteCare App from SBO Hearing A/S. The same remote wireless fitting option is available for the reference device
7
Oticon A/S´s Oticon Opn S™ air conduction hearing aids and all other Oticon devices on Velox S and Polaris platforms, legally marketed as class II, 510(k)-exempt devices.
As on the predicate Ponto 4 sound processors, volume and listening programs can be operated by the user via wireless accessories (incl. the Oticon On App).
Comparison table
| Modified device | Predicate device | Reference device | |
|---|---|---|---|
| Name | Ponto 5 Mini | Ponto 4 | |
| (K190540) | Oticon Opn S™ air | ||
| conduction hearing aid | |||
| (legally marketed, class II 510(k)- | |||
| exempt) | |||
| Intended Use | Improvement of hearing for patients | ||
| with conductive and mixed hearing | |||
| losses, whether unilaterally or | |||
| bilaterally fitted or for those with | |||
| single sided deafness. | Same | The hearing aid is intended to | |
| amplify and transmit | |||
| sound to the ear. | |||
| Indications for | |||
| Use | 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 45 dB HL for use | |||
| with the Ponto 5 Mini 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. | Same | Impaired hearing within mild to | |
| severe-to-profound hearing loss | |||
| Modified device | Predicate device | Reference device | |
| 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). | |||
| Sound | |||
| processing | |||
| features | OpenSound™ Navigator | ||
| Clear Dynamics | |||
| Transient Noise Management | |||
| Feedback Shield (LX) | |||
| 64 Processing channels | |||
| Speech Guard LX | |||
| Wind noise management | |||
| Battery management system | |||
| Fitting bandwidth of 10 kHz | |||
| OpenSound™ Optimizer | OpenSound™ Navigator | ||
| Clear Dynamics | |||
| Transient Noise Management | |||
| Feedback Shield (LX) | |||
| 64 Processing channels | |||
| Speech Guard LX | |||
| Wind noise management | |||
| Battery management system | |||
| Fitting bandwidth of 10 kHz | Same (+ additional) | ||
| Wireless | |||
| features | Receiver and transmitter, 2.4 GHz, | ||
| Bluetooth Low Energy | Same | Two wireless technologies with the | |
| commercial name TwinLink: |
- Receiver and transmitter, 2.4 GHz,
Bluetooth Low Energy - Receiver and transmitter, 3.84
MHz, Oticon proprietary NearLink |
| Coupling
features | Material: PEEK
Snap coupling outside the abutment | Same | N/A |
| Safety
Features | • Tamper proof battery drawer
• Maximum coupling safety release
force | • Tamper proof battery drawer
• Maximum coupling safety release
force | N/A |
| Accessories | Oticon Medical accessories:
• Head band, test band, softband
and SoundConnector
• Genie Medical BAHS fitting
software, version 2021.2
• Skins for personalization
Compatible wireless Oticon A/S
accessories:
• 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 fitting
software, version 2019.1 and 2021.2
• Skins for personalization
Compatible wireless Oticon A/S
accessories:
• Remote control 3.0
• ConnectClip
• TV Adapter 3.0
• EduMic
• Oticon ON App | Oticon A/S accessories:
• Genie 2 fitting software
Compatible wireless Oticon A/S
accessories:
• Remote control 3.0
• ConnectClip
• TV Adapter 3.0
• EduMic
• Oticon ON App
• Oticon RemoteCare App |
| | Modified device | Predicate device | Reference device |
| Fitting options | Wired fitting:
Hi-Pro 2
ExpressLink | Wired fitting:
Hi-Pro 2
ExpressLink | Wired fitting:
Hi-Pro 2
ExpressLink |
| | Wireless fitting:
Noahlink
RemoteCare App | Wireless fitting:
Noahlink | Wireless fitting:
Noahlink
RemoteCare App |
| Features in
fitting software | 16 channel frequency response
shaping
BC In-situ Audiometry
Feedback Analyzer
OpenSound™ - Transition
OpenSound™ - Noise reduction
controls
Wireless connection during fitting
Wireless accessories setting tool
Visual indicators setting
Data Logging
Technical Measurement tool
Verification tool
FLogram
Special Purpose Programs
RemoteCare option | 16 channel frequency response
shaping
BC In-situ Audiometry
Feedback Analyzer
OpenSound™ - Transition
OpenSound™ - Noise reduction
controls
Wireless connection during fitting
Wireless accessories setting tool
Visual indicators setting
Data Logging
Technical Measurement tool
Verification tool
FLogram | 16 channel frequency response
shaping
In-situ Audiometry
Feedback Analyzer
OpenSound™ - Transition
OpenSound™ - Noise reduction
controls
Wireless connection during fitting
Wireless accessories setting tool
Visual indicators setting
Special Purpose Programs
RemoteCare option |
8
9
Conclusion
The electrical and mechanical design of Ponto 5 Mini is unchanged from the predicate device, Ponto 4. The maximum force output and gain of the Ponto 5 Mini sound processor are equivalent to those provided by the predicate Ponto 4 sound processor. The minor technological differences between the Ponto 5 Mini sound processors and their predicate devices raise no new issues of safety or effectiveness. Using the same methods and success criteria, the performance data for the Ponto 5 Mini sound processors demonstrate that they are as safe and as effective as the Ponto 4 sound processors. Therefore, it is concluded that the Ponto 5 Mini sound processors are substantially equivalent to the Ponto 4 sound processors.