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 for the indicated ear should be better than 45 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, who for some reason will not or cannot use an AC CROS. The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

Device Description

The OBC bone anchored hearing aid 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 has a coupling so that it can be easily connected to and disconnected from the abutment by the user. The sound processor can alternatively be connected to headband accessories, to function as a conventional bone conductor.

AI/ML Overview

This document is a 510(k) premarket notification for the Oticon Medical OBC Bone Anchored Hearing Aid System, seeking substantial equivalence to a predicate device, the BAHA Divino. The provided text primarily focuses on demonstrating substantial equivalence rather than presenting an extensive study with specific acceptance criteria and performance metrics typically found for novel device claims.

However, based on the information provided, we can infer the "acceptance criteria" relate to the functional and performance characteristics that need to be "substantially equivalent" to an existing, legally marketed device. The "study" here is essentially the comparison and verification process detailed in the submission.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Since this is a substantial equivalence claim, the "acceptance criteria" are implicitly matching or performing equivalently to the predicate device, BAHA Divino. The "reported device performance" is the claim of equivalence.

Acceptance Criteria (Inferred from Predicate Device BAHA Divino)	Reported Device Performance (OBC Bone Anchored Hearing Aid System)
Design: Bone conduction sound processor connected to an implant surgically placed in the bone behind the deaf ear	Bone conduction sound processor connected to an implant surgically placed in the bone behind the deaf ear (Yes, substantially equivalent)
Intended Use: Improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single sided deafness	Improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single sided deafness (Yes, substantially equivalent)
Material: Implant: Titanium; Sound processor coupling: PEEK	Implant: Titanium; Sound processor coupling: PEEK (Yes, substantially equivalent)
Power Requirement: Zinc-air battery	Zinc-air battery (Yes, substantially equivalent)
Max Gain: 33dB	33 dB (Yes, substantially equivalent)
Frequency Response: 125 Hz - 8 kHz	125 Hz - 8kHz (Yes, substantially equivalent)
Sound Processing: Digital	Digital (Yes, substantially equivalent)
Safety and Efficacy: No new issues of safety and efficacy compared to predicate	No new issues of safety and efficacy compared to predicate (Concluded based on laboratory testing and comparison)

2. Sample size used for the test set and the data provenance

The document states: "Laboratory testing of the OBC system was conducted to determine device functionality and conformance to design input requirements." However, it does not specify a sample size for a test set (e.g., number of patients or devices tested). It also does not mention data provenance in terms of country of origin or whether it was retrospective or prospective, as the testing described appears to be internal laboratory testing for functional equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission is for substantiating equivalence based on technical specifications and functionality testing against a predicate device, not typical clinical performance evaluation requiring expert ground truth for a diagnostic or therapeutic outcome.

4. Adjudication method for the test set

Not applicable. There's no mention of an adjudication process as there isn't a clinical trial or performance study involving human interpretation of results requiring adjudication.

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 system, not an AI-powered diagnostic tool, and the submission does not describe an MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a bone-anchored hearing aid, which requires human interaction (wearing and using it) and is not an algorithm-only standalone system. The "standalone" performance here refers to the device's functional characteristics as described in the comparison table.

7. The type of ground truth used

The "ground truth" in this context is the established functional and performance characteristics of the predicate device, BAHA Divino. The OBC system's performance was compared against these established characteristics using laboratory testing. The submission confirms that the "intended use, function and procedure" of the OBC are substantially equivalent to the BAHA Divino.

8. The sample size for the training set

Not applicable. This is not an AI/ML device where a "training set" would be used in the conventional sense. The "training" for this device would refer to its design and engineering process, not data-driven model training.

9. How the ground truth for the training set was established

Not applicable. As above, there is no "training set" in the context of AI/ML device development.

Summary

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SECTION 2. SUMMARY AND CERTIFICATIONov 1 4 2008

510(K) SUMMARY A.

Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Oticon Medical summary for the OBC Bone anchored hearing aid system

SUBMITTER'S NAME:	Oticon Medical AB
ADDRESS:	Ekonomiv. 2SE-436 33 AskimSweden
CONTACT PERSON:	Karolin Isberg
TELEPHONE NUMBER:	+46 31 748 6153
FAX NUMBER:	+46 31 687 756
E-MAIL:	kai@oticon.se
DATE OF SUBMISSION:	July 18, 2008

Identification of device 1.

Proprietary Name: OBC Bone anchored hearing aid system Common Name: Hearing Aid, Bone Conduction Classification Status: Class Il per regulations 21 CER § 874.3300 Product Codes: LXB

Equivalent devices 2.

Oticon Medical believes that the OBC, regarding intended use, function and procedure, is substantially equivalent to BAHA Divino cleared in 510(k) K042017

Description of the Device 3.

Intended use 4.

The OBC is intended for improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single sided deafness

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Technological characteristics, comparison to predicate device ్.

Comparison table

Characteristics	BAHA Divino	OBC	S/Eq
Design	Bone conduction sound processorconnected to an implant whichhas been surgically placed in thebone behind the deaf ear	Bone conduction sound processorconnected to an implant whichhas been surgically placed in thebone behind the deaf ear	Yes
Intended use	Improvement of hearing forpatients with conductive andmixed hearing losses, bilateralfitting and single sided deafness	Improvement of hearing forpatients with conductive andmixed hearing losses, bilateralfitting and single sided deafness	Yes
Material	Implant: TitaniumSound processor coupling: PEEK	Implant: TitaniumSound processor coupling: PEEK	Yes
Powerrequirement	Zinc-air battery	Zinc-air battery	Yes
Max gain	33dB	33 dB	Yes
Frequencyresponse	125 Hz - 8 kHz	125 Hz - 8kHz	Yes
Soundprocessing	Digital	Digital	Yes
Manufacturer	Entific Medical Systems, Inc.	Oticon Medical AB
K-number	K042017	No number yet

Discussion of testing હ.

Laboratory testing of the OBC system was conducted to determine device functionality and conformance to design input requirements. These tests verify that the OBC is functionally equivalent to the to BAHA Divino from Entific Medical Systems, Inc., why we have come to the conclusion that further testing will not raise new issues of safety and efficacy.

7. Conclusion

Based on the comparison to the predicate device, the Oticon Medical OBC, is substantially equivalent to previously cleared predicate devices and presents no new concerns about safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Oticon Medical AB c/o Ms. Karolin Isberg QA/RA Manager Ekomomiv. 2 SE-436 33 Askim Sweden

NOV 1 4 2008

Re: K082108

Trade/Device Name: OBC Bone Anchored Hearing Aid System Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid, Bone Conduction Regulatory Class: Class II Product Code: LXB Dated: October 29, 2008 Received: October 31, 2008

Dear Ms. Isberg:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Marina B. Egleston, M.D.

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

Enclosure

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Page 1 of 1

K082108

B. INDICATIONS FOR USE

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: OBC Bone Anchored Hearing Aid System

Indications for Use:

The OBC is intended for the following patients and indications;

제 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 for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2 and 3 kI-Iz).
Bilateral fitting is applicable for most patients having a symmetrically conductive or 를 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.
新 Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear, who for some reason will not or cannot use an AC CROS. The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

The placement of a bone anchored implant is contraindicated for patients below the age of 5.

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

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

Daniel Ceffe

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

510(k) Number K082108

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.