(105 days)
Intended use:
The Ponto 3 sound processors are intended for improvements with conductive or mixed hearing losses, whether unilaterally or bilaterally fitted, or for those with single sided deafness.
Indications for use:
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower are intended for the following patients and indications:
· Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto 3 sound processor, 55 dB HL for use with the Ponto 3 Power sound processor and 65 dB HL for use with the Ponto 3 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.
· Indicated for 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 3, Ponto 3 Power and Ponto 3 SuperPower 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 3 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).
The Ponto 3, Ponto 3 Power and Ponto 3 SuperPower are modifications of the previously cleared Ponto Plus and Ponto Plus Power (K132775) and represent three latest sound processor models in the Ponto bone anchored hearing system. (Hereinafter referred to as the Ponto 3 sound processors or as the Ponto 3 family when referring to all three models and Ponto 3, Ponto 3 Power and Ponto 3 SuperPower when referring to the 3 different models.) A bone anchored hearing system consists of a sound processor connected to an implant with a skin penetrating abutment. The implant is surgically anchored in the skull bone behind the ear. Vibrations generated by the sound processor are transmitted via the implant directly through the skull bone to the cochlea as bone conduction sound. The sound processor has a coupling so that it can be easily connected to and disconnected from the abutment by the user. Alternatively, it can be connected to head band accessories, to function as a conventional bone conductor. Using a computer based fitting system the sound processor can be adjusted to the patient's individual hearing requirements. The Ponto 3 family is intended to be used with either the Ponto implant system or with specific compatible BAHA abutments/implants from Cochlear Bone Anchored Solutions (BAS).
The Ponto 3 family incorporates Inium Sense platform that is also used in the predicate Oticon A/S air conduction hearing aids legally marketed as class II. 510(k)-exempt devices. With the Injum Sense platform the microphone directionality system is updated. Furthermore, for Ponto 3 wireless transmission is enabled allowing for binaural signal processing.
In addition to the regular and power version sound processors, the Ponto 3 family introduces a SuperPower version with UltraDrive, consisting of a redesigned amplifier and optimized transducer. Ponto 3 SuperPower provides equivalent maximum force output (MFO) as the Baha Cordelle II, previously cleared through K080363, and thus expanded indication up to and including 65 dB HL is proposed.
This submission also includes minor modifications to the previously cleared accessories Genie Medical fitting software, Soft band and Streamer.
This document is a 510(k) premarket notification for the Ponto 3, Ponto 3 Power, and Ponto 3 SuperPower hearing aid devices. It aims to demonstrate substantial equivalence to previously marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here relate to demonstrating substantial equivalence with predicate devices, rather than specific performance metrics against a fixed standard. The "acceptance criteria" are implied by the comparisons made to predicate devices and the absence of new safety/efficacy concerns.
| Feature/Test | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Same intended use as Ponto Plus sound processors. | The Ponto 3 sound processors have the same intended use as the Ponto Plus sound processors (Reference: Section 6). |
| Indications for Use (Ponto 3, Ponto 3 Power) | Same indications as Ponto Plus and Ponto Plus Power, respectively. | Ponto 3 and Ponto 3 Power have the same indications as the Ponto Plus and Ponto Plus Power (Reference: Section 6). |
| Indications for Use (Ponto 3 SuperPower) | Same indications as Ponto Plus Power, but with an expanded bone-conduction hearing threshold up to 65 dB HL, equivalent to Baha Cordelle II. | Ponto 3 SuperPower has the same indications as Ponto Plus Power, except the bone-conduction hearing threshold that is 55 dB HL for Ponto Plus Power and 65 dB HL for Ponto 3 SuperPower. Indications of the Ponto 3 SuperPower are the same as those of the Baha Cordelle II (Reference: Section 6). |
| Electromagnetic Compatibility (EMC) | Not emit excessive amounts of electromagnetic energy (EMC emissions); operate as intended without performance degradation in the presence of an electromagnetic disturbance (EMC immunity) and ESD (for Ponto 3 SuperPower). Update from Inium to Inium Sense and new features do not affect EMC for Ponto 3 and Ponto 3 Power. | Ponto 3 SuperPower sound processors have been tested to meet EMC emissions, immunity, and ESD requirements. Updating from the previously cleared Inium platform to Inium Sense and addition of the new sound processing features do not affect the electromagnetic compatibility of Ponto 3 and Ponto 3 Power, thus no new verification tests regarding EMC have been carried out on them (Reference: Section 5). |
| Electroacoustical Performance | Operate as intended across frequency range, Peak OFLs, total harmonic distortion, and equivalent input noise. Update from Inium to Inium Sense and new features do not affect acoustical performance for Ponto 3 and Ponto 3 Power. | Electroacoustical verification has been conducted for Ponto 3 SuperPower, including tests for battery voltage and current consumption, frequency range, Peak OFLs at 90, 60 and 50 dB SPL, total harmonic distortion and equivalent input noise. The current consumption and battery voltage have been verified for the Ponto 3 and Ponto 3 Power sound processors. Updating from Inium to Inium Sense and new features do not affect the acoustical performance of Ponto 3 and Ponto 3 Power, thus no new verification tests regarding electroacoustical performance have been carried out on them (Reference: Section 5). |
| Battery Voltage & Current Consumption | Verified for Ponto 3 & Ponto 3 Power. | The current consumption and battery voltage have been verified for the Ponto 3 and Ponto 3 Power sound processors (Reference: Section 5). |
| Binaural Coordination | Verified functional equivalence to predicate Oticon A/S air conduction hearing aids. | Bench tests were conducted to verify the binaural coordination, and it was found functionally equivalent to the same of the predicate Oticon A/S air conduction hearing aids (Reference: Section 5). |
| Updated Microphone Directionality System | Verified functional equivalence to predicate Oticon A/S air conduction hearing aids. | Bench tests were conducted to verify the updated microphone directionality system, and it was found functionally equivalent to the same of the predicate Oticon A/S air conduction hearing aids (Reference: Section 5). |
| Maximum Force Output (MFO) and Gain (Ponto 3 SuperPower) | Equivalent to or higher than the Baha Cordelle II. | The maximum output force measurements show that the MFO and gain of the Ponto 3 SuperPower is equivalent or higher when compared to the output of the predicate Baha Cordelle II sound processor (Reference: Section 5). |
| Overall Safety and Effectiveness | No new issues of safety or effectiveness compared to predicate devices. | The minor technological differences between the Ponto 3 sound processors and their predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Ponto 3 sound processors are as safe and effective as the Ponto Plus sound processors and that the Ponto 3 SuperPower is as safe and effective as the Baha Cordelle II sound processor (Reference: Section 6). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes functional testing and firmware validation for the Ponto 3 sound processors.
- Sample Size: The document does not specify a "test set" sample size in terms of patient data or clinical trials. The testing seems to be primarily bench testing on the devices themselves.
- Data Provenance: Not applicable as it primarily describes bench testing, not patient data from a specific country or whether it was retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this submission is based on engineering specifications and performance measurements against established standards for hearing aids and comparison to predicate devices, rather than expert interpretation of a clinical dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a human adjudication method, as the testing described is technical/bench-based.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a hearing aid, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device itself (hearing aid) without a human "in-the-loop" as a diagnostic interpreter. The "Performance data" section (Section 5) describes standalone performance testing:
- Ponto 3 SuperPower underwent EMC emissions, immunity, and ESD tests.
- Electroacoustical verification was conducted for Ponto 3 SuperPower (battery voltage, current consumption, frequency range, Peak OFLs, THD, EIN).
- Current consumption and battery voltage were verified for Ponto 3 and Ponto 3 Power.
- Bench tests were conducted to verify binaural coordination and updated microphone directionality system.
- Maximum output force measurements were done for Ponto 3 SuperPower.
These indicate standalone testing of the device's technical specifications and performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for demonstrating substantial equivalence is based on:
- Engineering Specifications and Performance Standards: The device's technical performance (e.g., EMC, electroacoustical output, MFO) against established industry standards for hearing aids.
- Predicate Device Performance: Comparison to the known and cleared performance characteristics of the Ponto Plus sound processors, Ponto Plus Power, Baha Cordelle II, and existing Class II 510(k)-exempt Oticon A/S air conduction hearing aids.
- Functional Equivalence: Demonstrating that new features (binaural signal processing, updated microphone directionality) are functionally equivalent to those in legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This device is a medical device (hearing aid), not an AI algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable, as no training set is used for this type of device.
§ 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.