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).

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 (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.

AI/ML Overview

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.

Characteristic	Acceptance Criteria (Predicate: Baha Intenso K081606)	Reported Device Performance (Ponto Pro Power)	Device Meets Criteria?
Indications for Use	Improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting, and single-sided deafness.	Equivalent indications for use.	Yes
Pure tone average bone conduction threshold (conductive/mixed hearing loss)	Better than or equal to 55 dB HL (measured at 0.5, 1, 2, 3 kHz)	Verified to successfully fit the same patient population, i.e., those with bone-conduction thresholds of < 55 dB HL.	Yes
Max gain at 1600 Hz	45 dB	47 dB	Yes (within acceptable equivalence, and potentially improved)
Wind Noise Reduction	N/A (new feature)	Bench performance data verify that device responds to airflow by reducing overall gain and switching mode.	Yes
Dynamic Feedback Cancellation (DFC)	N/A (new feature)	Bench performance data show feedback is identified and cancelled without artifacts.	Yes
Speech Guard	N/A (new feature)	Bench testing shows ability to maintain linear processing while responding to rapid environmental sounds, less distortion than traditional compression.	Yes
BC In-situ Audiometry	N/A (new feature, but equivalent to Baha BP 100)	Difference compared to conventional unmasked BC hearing thresholds (audiometer with RadioEar B-71 transducer) is on average less than 5 dB.	Yes
Aided Thresholds	Essentially similar to predicate device (Baha Intenso)	Essentially similar for both devices; no significant differences observed.	Yes
Speech Perception in Quiet	Equivalent to predicate device (Baha Intenso)	Verified to be substantially equivalent to predicate device.	Yes
Speech Perception in Noise	Equivalent to predicate device (Baha Intenso)	Verified to be substantially equivalent to predicate device.	Yes
Subjective Evaluation (Wind Noise & Feedback)	Equivalent to predicate device (Baha Intenso)	Verified to be substantially equivalent to predicate device.	Yes

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.

Summary

{0}------------------------------------------------

K103594

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.

{1}------------------------------------------------

3. Description of the device

· 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).

{2}------------------------------------------------

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	BahaIntenso™	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

{3}------------------------------------------------

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 < 55 dB HL. 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. Therefore Ponto Pro Power is considered to successfully fit the same patient population; i.e. those with bone-conduction thresholds of < 55 dB HL.

Verification of the safety and effectiveness of the new sound processing features introduced for Ponto Pro Power: Wind noise reduction. Dynamic Feedback Cancellation. Speech Guard and BC In-situ Audiometry include bench performance testing as well as clinical evaluation. 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 patients 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.

7 Conclusion

Based on the comparison to the predicate devices, the Oticon Medical Ponto Pro Power, is substantially equivalent to devices already on the market cleared by the 510(k) process.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration. 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Oticon Medical AB c/o Ms. Ulrika Nielson Ouality and Regulatory Manager Ekonomiv. 2 SE-436 33 Askim Sweden

JUN 1 5 201

Re: K103594

Trade/Device Name: Ponto Pro Power Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid, Bone Conduction Regulatory Class: Class II Product Code: LXB Dated: May 3, 2011 Received: May 6, 2011

Dear Ms. Nielson:

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. 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

{5}------------------------------------------------

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fdagov/MedicalDevices/Safety/ReportaProblem/default.h1m for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erlacher. mf.

Malvina B. Eydelman, M Director Division of Ophthalmic. Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

{6}------------------------------------------------

B. INDICATIONS FOR USE

510(k) Number:

Device Name: Ponto Pro Power

Indications for Use:

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.

Over -The-Counter Use Prescription Use X OR (Part 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Van Raalt

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear Nose and Throat Devices

510(k) Number K103594

Regulation Number and Section

§ 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.