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The Ponto Pro Power is 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 of the indicated ear should be better than or equal to 55 dB HL (measured at 0.5, 1, 2 and 3 kHz)
• 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 Pro Power sound processor is intended to be connected to the Oticon Medical bone anchored implant system or to the Baha@ Abutment snap coupling from Cochlear Bone Anchored Solutions AB (ref no. 90410, 90305, 90434, 90480).

Ponto Pro Power is a bone conduction hearing aid which is connected to an implant with a skin penetrating abutment which has been 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. Ponto Pro Power has a coupling so that it can easily be connected and disconnected from the abutment by the user or alternatively from a head band accessory, to function as a conventional bone conductor. Using a computer based fitting system, Genie Medical; Ponto Pro Power can be adjusted to the patient's individual hearing requirements. Ponto Pro Power contains a number of advanced features: Wind Noise Reduction, Feedback Management System (Feedback Manager and Dynamic Feedback Cancellation), Automatic Gain Control, Speech Guard, BC In-situ Audiometry, Automatic Multiband Adaptive Directionality, Tri-state Noise Reduction, Data Logging, and Learning Volume Control.

Here's a breakdown of the acceptance criteria and study information for the Oticon Medical Ponto Pro Power bone-anchored sound processor, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily established through substantial equivalence to predicate devices, particularly the Baha Intenso (K081606). The device performance is verified through bench testing and clinical evaluation comparing it to the predicate.

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

• Sample Size:
  • Clinical Evaluation comparing Ponto Pro Power to Baha Intenso: 20 experienced users of Intenso; 18 subjects with mixed hearing losses and 2 with single-sided deafness. Only the 18 subjects with conductive and mixed hearing losses were analyzed for the equivalence study.
  • BC In-situ Audiometry verification: 25 hearing-impaired patients.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data but mentions the submitter is Oticon Medical AB in Sweden. The study is described as "unpublished" and "funded by the submitter," indicating it was a prospective study conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• For the clinical evaluation comparing Ponto Pro Power to Baha Intenso: The "ground truth" here is the performance of the predicate device (Baha Intenso), against which the Ponto Pro Power is compared. The study involved "experienced users of Intenso," implying their established hearing experience with the predicate device served as a baseline.
• For BC In-situ Audiometry verification: The ground truth for audiometric BC thresholds was established using "conventional unmasked BC hearing thresholds...with an audiometer using a RadioEar B-71 bone conduction transducer." This is a standard clinical method for establishing audiometric ground truth.
• Number of Experts: Not explicitly stated how many audiologists or other experts conducted measurements or assessments, but it implies standard clinical practice by qualified professionals. Their specific qualifications (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the clinical data. The clinical evaluation involved direct comparisons of objective measures (aided thresholds, speech perception) and subjective measures (APHAB, SSQ, questionnaires on user experience, satisfaction, and preference). For the BC In-situ Audiometry, it was a direct comparison of measurement methods.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned. The study involved individual patients being tested with both the predicate device and the new device. The "before-and-after" or "cross-over" nature of the clinical study (users tested with Intenso prior to testing with Ponto Pro Power) allowed for direct comparison within individuals.

• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as this is a hearing aid device, not an AI diagnostic tool primarily interpreted by human "readers." The "AI" features (Wind Noise Reduction, DFC, Speech Guard, Automatic Multiband Adaptive Directionality, Tri-state Noise Reduction, Learning Volume Control) are integrated into the device's signal processing to directly improve the listener's experience, not to assist human interpretation of data.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone (algorithm only) performance was done through bench performance testing for the new sound processing features:

• Wind Noise Reduction: Tested when exposed to a "preset air flow" to verify response (reducing gain, switching mode).
• Dynamic Feedback Cancellation (DFC): Tested to show feedback is identified and cancelled without artifacts.
• Speech Guard: Tested "at different gain settings, input levels, and different types of noise input" to confirm linear processing and instantaneous response to environmental sounds.
• BC In-situ Audiometry: Compared the device's measurement (via the sound processor) directly against a conventional audiometer with a specified transducer to evaluate its accuracy as a measurement tool.

7. Type of Ground Truth Used

• For demonstrating substantial equivalence in overall hearing improvement: The ground truth was the performance of the legally marketed predicate device (Baha Intenso), as measured by aided thresholds, speech perception in quiet, speech perception in noise, and subjective user feedback.
• For BC In-situ Audiometry: The ground truth was conventional audiometric measurements obtained using a standard audiometer and RadioEar B-71 bone conduction transducer.
• For new sound processing features (Wind Noise Reduction, DFC, Speech Guard): The ground truth was established by engineering design criteria and expected functional behavior verified through controlled bench tests.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development or any machine learning algorithms. The device's features (like Learning Volume Control or Automatic Multiband Adaptive Directionality) likely use internal algorithms that may have been developed and refined using R&D data, but no formal "training set" with a specified sample size is detailed in this regulatory summary.

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

Since no formal "training set" is described for algorithm development, the method for establishing its ground truth is not provided. The Ponto Pro Power's advanced features rely on signal processing and environmental analysis, which would typically be developed based on audiology principles, acoustic modeling, and potentially large datasets of sound environments and user preferences, but these details are not part of this 510(k) summary.

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