(20 days)
No
The document explicitly states that no functionality or features of the firmware are changed, added, or removed compared to the predicate device, and there is no mention of AI or ML in the description of the device or its software.
Yes.
The device is a bone-anchored hearing system intended to improve hearing for patients with various types of hearing loss, which is a therapeutic function.
No
This device is a sound processor intended to improve hearing for patients with hearing loss, not to diagnose the condition. The fitting software adjusts the sound processor based on a patient's audiogram, which is a pre-existing diagnostic measure, rather than performing diagnosis itself.
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 is associated software (Genie Medical BAHS fitting software), the core medical device is a hardware system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Ponto 5 SuperPower sound processor is a bone-anchored hearing system. It works by transmitting sound vibrations through the skull bone to the cochlea to improve hearing. This is a mechanical and electronic process, not a diagnostic test performed on a biological sample.
- Intended Use: The intended use is to improve hearing for patients with specific types of hearing loss. It does not involve diagnosing a disease or condition.
- Device Description: The description details the components of the hearing system and how it functions to transmit sound. There is no mention of analyzing biological samples.
Therefore, the Ponto 5 SuperPower sound processor falls under the category of a hearing aid or prosthetic device, not an in vitro diagnostic device.
No
Explanation: The FDA clearance letter does not mention any authorization for a Predetermined Change Control Plan (PCCP) for this device. A PCCP is an explicit designation granted by the FDA to allow manufacturers to make certain pre-specified modifications to a device without needing a new 510(k) submission. This information would be clearly stated in the clearance if it were authorized.
# Intended Use / 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.
· 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 (comma separated list FDA assigned to the subject device)
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 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](https://510k.innolitics.com/search/K161671)) and predicate Ponto 5 Mini ([K211640](https://510k.innolitics.com/search/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](https://510k.innolitics.com/search/K161671)), to allow for a side neutral design that carries the same design and look as Ponto 5 Mini ([K211640](https://510k.innolitics.com/search/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](https://510k.innolitics.com/search/K161671) for Ponto 3 SuperPower and [K211640](https://510k.innolitics.com/search/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](https://510k.innolitics.com/search/K211640)).
- -The Softband, previously cleared through [K082108](https://510k.innolitics.com/search/K082108) and latest in [K161671](https://510k.innolitics.com/search/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.
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
bone behind the ear (temporal bone)
# Indicated Patient Age Range
The placement of a bone anchored implant is contraindicated for patient below the age of 5.
# Intended User / Care Setting
Hearing Care Professional (HCP)
# 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 SuperPower sound processors is produced using the same well-established methods as for primary predicate Ponto 3 SuperPower ([K161671](https://510k.innolitics.com/search/K161671)) and predicate Ponto 5 Mini ([K211640](https://510k.innolitics.com/search/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](https://510k.innolitics.com/search/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](https://510k.innolitics.com/search/K161671)) and predicate Ponto 5 Mini ([K211640](https://510k.innolitics.com/search/K211640)).
# Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
# Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
[K161671](https://510k.innolitics.com/search/K161671), [K211640](https://510k.innolitics.com/search/K211640)
# Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
[K082108](https://510k.innolitics.com/search/K082108)
# Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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
1
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
2
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:
· 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).
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
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3
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 |
4
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.
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.
5
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.
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.
6
- . 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.
7
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.
8
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) | ||
| 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 as for Ponto 5 | ||
| SuperPower | Same as for Ponto 5 | ||
| SuperPower | |||
| 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 65 dB | |||
| HL. |
• 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 | Same as for Ponto 5
SuperPower | Same, except that patient's
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 (as opposed to
the 65 dB HL for Ponto 3
SuperPower and Ponto 5
SuperPower). |
| | Modified device | Primary predicate device | Predicate device |
| | Ponto 5 SuperPower | Ponto 3 SuperPower | Ponto 5 Mini |
| | | (K161671) | (K211640) |
| | • 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). | | |
| Sound
processing
features | OpenSound Navigator™
OpenSound Optimizer™
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 | FreeFocus (directionality
system)
Tri-state Noise Reduction
Inium Sense feedback shield
15 sound processing channels
Speech Guard
Wind Noise Reduction
Battery management system
Binaural Processing
Fitting bandwidth of 10 kHz | Same as for Ponto 5
SuperPower |
| Wireless
features | Receiver and transmitter, 2.4
GHz, Bluetooth® Low Energy | Wireless connections to
external devices through the
Oticon Medical Streamer
(using NFMI 3.84 MHz
connection). | Same as for Ponto 5
SuperPower |
| Coupling
features | Material: PEEK
Snap coupling outside the
abutment | Same as for Ponto 5
SuperPower | Same as for Ponto 5
SuperPower |
| Safety
Features | • Tamper-resistant battery
drawer
• Maximum coupling safety
release force | Same as for Ponto 5
SuperPower | • Tamper-resistant battery
drawer option included in the
sales package
• Maximum coupling safety
release 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 fitting
software, version 2022.1
• Skins for personalization
Compatible wireless Oticon
A/S/SBO Hearing 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 2016.1
• Skins for personalization
Compatible wireless Oticon
A/S accessories:
• Oticon Medical Streamer | Same as for Ponto 5
SuperPower
(Compatible with Genie
Medical BAHS fitting software,
version 2021.2 and 2022.1) |
| Fitting
options | Wired fitting:
Hi-Pro 2
ExpressLink
Wireless fitting:
Noahlink wireless
Oticon RemoteCare app | Wired fitting:
Hi-Pro 2
ExpressLink | Same as for Ponto 5
SuperPower |
| Features in
fitting
software | 16 channel frequency
response shaping
BC In-situ Audiometry
Feedback Analyzer
Data Logging
Automatics (OpenSound
settings, Transient Noise
Reduction settings and
Silencer Control)
Single-sided deafness fitting
mode
Soft band fitting mode
Wireless connection during
fitting
Wireless accessories setting
tool
Visual and audible indicators
setting
Technical Measurement tool
Verification tool
FLogram
Program Manager
Special Purpose Programs
RemoteCare option | 10 fitting frequency response
shaping
BC In-situ Audiometry
Feedback Manager
Data Logging
Automatics (directionality
mode and noise management)
Single-sided deafness fitting
mode
Soft band fitting mode
Fitting Assistant
Wireless accessories setting
tool (ConnectLine)
Audible indicator setting
Technical Measurement tool
Verification tool
FLogram
Program Manager | Same as for Ponto 5
SuperPower |
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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).