(112 days)
No
The summary describes a bone-anchored hearing aid system that transmits sound through bone conduction. There is no mention of AI or ML in the intended use, device description, or performance studies. The comparison to a predicate device also focuses on functional equivalence, not advanced processing capabilities.
Yes.
The device is a bone-anchored hearing aid system that treats hearing loss by transmitting sound directly to the cochlea, which is a therapeutic function.
No
Explanation: The device is described as a "bone anchored hearing aid system," which is a therapeutic device designed to amplify sound. Its "Intended Use" focuses on treating hearing loss, not diagnosing it.
No
The device description explicitly states that the system consists of an external sound processor unit and an implant with a skin penetrating abutment, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The OBC is a bone-anchored hearing aid system. It works by transmitting sound vibrations through the bone to the cochlea to improve hearing. It does not analyze biological samples.
- Intended Use: The intended use is to treat hearing loss by providing amplification and sound transmission, not to diagnose a condition based on in vitro analysis.
- Device Description: The description details a physical device with an external processor and an implant, not a test kit or analytical instrument for biological samples.
Therefore, the OBC falls under the category of a medical device, specifically a hearing aid system, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The OBC is intended for the following patients and indications;
- 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 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).
Product codes
LXB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear / bone behind the ear
Indicated Patient Age Range
The placement of a bone anchored implant is contraindicated for patients below the age of 5.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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. 2 |
| SE-436 33 Askim | |
| Sweden | |
| 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.
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.
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
1
Technological characteristics, comparison to predicate device ్.
Comparison table
| Characteristics | BAHA Divino | OBC | S/Eq |
|---|---|---|---|
| Design | Bone conduction sound processor | ||
| connected to an implant which | |||
| has been surgically placed in the | |||
| bone behind the deaf ear | Bone conduction sound processor | ||
| connected to an implant which | |||
| has been surgically placed in the | |||
| bone behind the deaf ear | Yes | ||
| 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 | ||
| Material | Implant: Titanium | ||
| Sound processor coupling: PEEK | Implant: Titanium | ||
| Sound processor coupling: PEEK | Yes | ||
| Power | |||
| requirement | Zinc-air battery | Zinc-air battery | Yes |
| Max gain | 33dB | 33 dB | Yes |
| Frequency | |||
| response | 125 Hz - 8 kHz | 125 Hz - 8kHz | Yes |
| Sound | |||
| processing | 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.
3
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
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.
OR
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