(189 days)
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No
The device description lists several "advanced features" such as Wind Noise Reduction, Feedback Management System, Automatic Gain Control, Speech Guard, etc. While these features involve signal processing and adaptation, the description does not explicitly mention or imply the use of AI or ML algorithms for these functions. The fitting system is described as "computer based," which is standard for modern hearing aids and does not necessarily indicate AI/ML.
Yes
The device is a bone conduction hearing aid intended to amplify sound for individuals with hearing loss, which is a therapeutic function.
No
Explanation: A diagnostic device is used to detect, diagnose, or monitor a disease, condition, or health status. The Ponto Pro Power is a hearing aid, which is a therapeutic device designed to amplify sound and improve hearing, not to diagnose a condition. While it has a "BC In-situ Audiometry" feature, this is for adjusting the hearing aid to the patient's individual needs and verifying its effect, not for primary diagnosis.
No
The device description clearly states that the Ponto Pro Power is a bone conduction hearing aid which is a physical hardware device connected to an implant. While it uses software for fitting and advanced features, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to amplify sound and transmit it through bone conduction to improve hearing for individuals with specific types of hearing loss. This is a therapeutic and assistive function, not a diagnostic one.
- Device Description: The device is described as a bone conduction hearing aid. Hearing aids are considered medical devices, but not IVDs.
- Lack of Diagnostic Purpose: The device does not analyze biological samples (blood, tissue, etc.) to diagnose a disease or condition. While it uses audiometry data for fitting, the device itself is not performing the diagnostic test. The BC In-situ Audiometry feature is a tool within the hearing aid to help with fitting, not a standalone diagnostic test.
- Performance Studies: The performance studies focus on the device's ability to improve hearing and its equivalence to predicate hearing aids, not on its ability to diagnose a condition.
In summary, the Ponto Pro Power is a medical device designed to treat hearing loss by amplifying sound, not to diagnose a condition by analyzing biological samples.
N/A
Intended Use / Indications for Use
The Ponto Pro Power sound processor is intended for improvement of hearing for patients with conductive and mixed losses, bilateral fitting and single sided deafness.
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 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).
Product codes (comma separated list FDA assigned to the subject device)
LXB
Device Description
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
- Automatic Gain Control
- Speech Guard
- BC In-situ Audiometry
- Automatic Multiband Adaptive Directionality
- Tri-state Noise Reduction
- Data Logging
- Learning Volume Control
The sound processor is intended to work with the Oticon Medical bone anchored implant system or the Baha Abutment snap coupling from Cochlear BAS (ref no. 90410, 90305, 90434, 90480).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Behind the ear/skull 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
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench performance data has verified the Ponto Pro Power to be equivalent to the predicate device in terms of device gain and maximum force output. Bench performance data of the wind noise reduction feature verify that when exposed to a preset air flow the device responds to the air flow/wind by reducing overall gain and switching mode, respectively. Bench performance data on the Dynamic Feedback Cancellation (DFC) feature show that feedback is identified and cancelled out by the DFC system without artifacts being introduced. Bench testing of the Speech guard feature include testing of the behavior of Speech Guard at different gain settings, input levels, and different types of noise input and shows that the device is able to maintain linear processing as much as possible, while at the same time responding instantaneously to rapidly occurring environmental sounds. The bench data confirms the effectiveness of the sound processing features and ensure that no negative effects are introduced.
Clinical data include comparisons with the predicate device Baha Intenso (K081606). In an unpublished study funded by the submitter, performance data of both instruments were collected from 20 experienced users of Intenso, 18 subjects had mixed hearing losses and 2 were single-sided deaf. Only results from the homogenous group of the 18 subjects with conductive and mixed hearing losses were analyzed. 5 subjects were male and 13 female. The age range between 17 years and 75 years, average age of the subjects was 58.1 years, SD 14.53 years. All subjects had used Baha Intenso for at least 4 months and were tested with the Intenso prior to testing with the Ponto Pro Power. Performance of both devices was evaluated objectively in terms of aided thresholds, speech perception in quiet and speech perception in noise. Abbreviated Profile of Hearing Aid Benefit (APHAB) and the Speech Spatial and Quality Scale of Hearing (SSO). In addition, user experiences, user satisfaction, and device preference among subjects were probed via questionnaires. The aided thresholds were essentially similar for both devices; no significant differences were observed between the two devices.
Ponto Pro Power was verified to be substantially equivalent to the predicate device Baha Intenso, both concerning subjective evaluation on wind noise and feedback and in terms of speech reception threshold in quiet and speech reception threshold in noise.
To verify the effect of BC In-situ Audiometry conventional unmasked BC hearing thresholds was measured with two methods for a group of 25 hearing impaired patients, an audiometer using a RadioEar B-71 bone conduction transducer and the BC In-situ Audiometry tool in Genie Medical via the sound processor on the patient's abutment. The difference between both measurement methods is on average less than 5 dB. Taking audiometric step size (5 dB) and size of population into account, both measurement methods can be regarded as similarly sensitive for audiometric BC threshold measurements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K081606, K082108, K090996, K090720
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.
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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).
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§ 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
JUN 1 5 2011
SECTION 2. SUMMARY AND CERTIFICATION
A. 510(K) SUMMARY
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the Oticon Medical summary for the Ponto Pro Power bone anchored sound processor.
SUBMITTER'S NAME: ADDRESS:
CONTACT PERSON: TELEPHONE NUMBER: FAX NUMBER: E-MAIL: DATE OF SUBMISSION: Oticon Medical AB Ekonomivägen 2 SE-436 33 Askim Sweden
Ulrika Nielsen +46 31 748 61 66 +46 31 687 756 uln@oticonmedical.se December 1, 2010
- Identification of device 1.
Proprietary Name: Common Name: Classification Status: Product Code:
Ponto Pro Power Hearing Aid, Bone Conduction Class II per regulations 21 CFR § 874.3300 LXB
2. Equivalent devices
Oticon Medical believes that the Ponto Pro Power, regarding intended use, function, procedure and fitting, is substantially equivalent to the Ponto and Ponto Pro cleared in K082108 and K090996. The indications for use are equivalent to the Baha® Intenso™ cleared in K081606. The ability to measure bone-conduction thresholds directly via pure tones generated by the sound processor (BC In-Situ Audiometry), is substantially equivalent to the Baha® BP 100 in K090720.
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3. Description of the device
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 Depending on the wind noise level, sounds will be attenuated. The more wind, the more attenuation. In Ponto Pro Power the Wind Noise Reduction system will - in addition force the instrument into Omni directionality mode.
- · Feedback Management System The Feedback Management System consists of two parts: Feedback Manager and Dynamic Feedback Cancellation.
- The Feedback Manager is a tool in Genie Medical that measures and applies feedback limits in O the sound processor. The feedback limits are set to prevent static feedback and to facilitate the full use of the entire range of the volume control without feedback.
- Dynamic Feedback Cancellation (DFC) is a feature in the sound processor that constantly checks 0 for the presence of acoustic feedback. When feedback is detected, the DFC system phase cancels the feedback signal. DFC is designed to minimize the risk of feedback by adapting to sudden acoustical changes.
- · Automatic Gain Control Ponto Pro Power has an Automatic Gain Control that adjusts the gain to the environment. The Automatic Gain Control can work both over the whole frequency range and in each of the 10 frequency bands. There is an output AGC that ensures there is no distorted peak clipped signal at saturation level of the instrument. A peak clipped signal distorts the sinus signal. By avoiding this distortion, increased sound comfort is achieved.
- · Speech Guard Speech Guard is a signal processing system that works by maintaining linear processing as much as possible, but at the same time responding instantaneously to rapidly occurring environmental sounds - Speech Guard is designed to produce less distortion than traditional compression systems.
- BC In-situ Audiometry BC In-situ Audiometry is a tool in Genie Medical for measuring the . patient's bone conduction hearing thresholds directly via the sound processor.
- · Automatic Multiband Adaptive Directionality The system analyzes information from various environmental detectors and automatically chooses one of the three different directionality modes with the aim of automatically offering an improved speech to noise ratio in adverse listening situations. The directionality modes are Omni, Split Directionality and Full Directionality.
- · Tri-state Noise Reduction The Tri-state Noise Reduction system continuously analyzes the environment and aims at providing the appropriate amount of attenuation in different listening environments. It includes the detection of speech, environmental background noise and wind noise. The system automatically moves seamlessly between the different states. The aim of this system is to provide some degree of comfort in noisy environments while preserving the information most important for speech intelligibility.
- · Data Logging Data Logging permits the Ponto Pro Power to memorize listening levels, usage time, user settings and system states. The data can be analyzed externally, providing the audiologist and the patient with valuable information can be used to adjust the system settings in order to optimize patient comfort and speech intelligibility in any complex listening situation.
- · Learning Volume Control The Learning Volume Control enables the hearing system to adjust automatically to patient preferences over time. Different listening situations and preferred volume settings are memorized. The system continuously analyzes listening situations and automatically adjusts the volume to the memorized preferred setting. In this way the system assists to get the preferred volume for the patient without his/hers manual adjustment of the volume control.
The sound processor is intended to work with the Oticon Medical bone anchored implant system or the Baha Abutment snap coupling from Cochlear BAS (ref no. 90410, 90305, 90434, 90480).
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4. Intended Use
The Ponto Pro Power sound processor is intended for improvement of hearing for patients with conductive and mixed losses, bilateral fitting and single sided deafness.
| Characteristics | Ponto Pro | Ponto Pro | BP100 | Baha
Intenso™ | S/Eq |
|---------------------|--------------------|--------------------|--------------------|--------------------|------|
| | Power | | | | |
| Design | Bone conduction | Bone conduction | Bone conduction | Bone conduction | Yes |
| | sound processor | sound processor | sound processor | sound processor | |
| | connected to an | connected to an | connected to an | connected to an | |
| | implant which | implant which | implant which | implant which | |
| | has been | has been | has been | has been | |
| | surgically placed | surgically placed | surgically placed | surgically placed | |
| | in the bone | in the bone | in the bone | in the bone | |
| | behind the ear | behind the ear | behind the ear | behind the ear | |
| | | | | | |
| Indications for use | Improvement of | Improvement of | Improvement of | Improvement of | Yes |
| | hearing for | hearing for | hearing for | hearing for | |
| | patients with | patients with | patients with | patients with | |
| | conductive and | conductive and | conductive and | conductive and | |
| | mixed hearing | mixed hearing | mixed hearing | mixed hearing | |
| | losses, bilateral | losses, bilateral | losses, bilateral | losses, bilateral | |
| | fitting and single | fitting and single | fitting and single | fitting and single | |
| | sided deafness | sided deafness | sided deafness | sided deafness | |
| | | | | | |
| Pure tone average | Better than or | Better than or | Better than or | Better than or | Yes |
| bone conduction | equal to 55 dB | equal to 45 dB | equal to 45 dB | equal to 55 dB | |
| threshold of the | HL (measured at | HL (measured at | HL (measured at | HL (measured at | |
| indicated ear for | 0.5, 1, 2, 3) | 0.5, 1, 2, 3 kHz) | 0.5, 1, 2, 3 kHz) | 0.5, 1, 2, 3) | |
| patients with | | | | | |
| conductive or | | | | | |
| mixed hearing loss | | | | | |
| Material | Sound processor | Sound processor | Sound processor | Sound processor | Yes |
| | coupling: PEEK | coupling: PEEK | coupling: PEEK | coupling: PEEK | |
| Power requirement | Zinc-air battery | Zinc-air battery | Zinc-air battery | Zinc-air battery | Yes |
| Max gain at 1600 | 47 dB | 33 | 33 | 45 dB | Yes |
| Hz | | | | | |
| Frequency response | 125 Hz-8 kHz | 125 Hz - 8 kHz | 250 Hz-7 kHz | 250 Hz - 7 kHz | Yes |
| Sound processing | Digital | Digital | Digital | Digital | Yes |
| Patient fitting | Individual | Individual | Individual | Individual | Yes |
| | adjustment to | adjustment to | adjustment to | adjustment to | |
| | patient | patient | patient | patient | |
| | audiogram and | audiogram and | audiogram and | audiogram and | |
| | needs by a | needs by a | needs by a | needs by | |
| | computer based | computer based | computer based | potentiometers | |
| | fitting system | fitting system | fitting system | adjusted by the | |
| | used by the | used by the | used by the | audiologist using | |
| | audiologist. | audiologist. | audiologist. | a screwdriver. | |
| Manufacturer | Oticon Medical | Oticon Medical | Cochlear Bone | Cochlear Bone | Yes |
| | AB | AB | Anchored | Anchored | |
| | | | Solutions AB | Solutions AB | |
| K-number | No number yet | K090996 | K090720 | K081606 | |
5. Technological characteristics, comparison to predicate device
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6 Discussion of testing
Testing of the Ponto Pro Power has been performed to verify design criteria and device performance with respect to mechanical, electroacoustical and software properties.
Published data in the literature support the safety and efficacy of the predicate device, Baha Intenso for patients with average bone-conduction thresholds of