(30 days)
Not Found
No
The summary describes a bone conduction hearing aid and its intended use, but there is no mention of AI or ML technology in the device description, performance studies, or key metrics.
No.
The document describes the device as a bone conduction-type hearing aid intended for sound amplification, which is a compensatory or assistive function rather than a direct therapeutic intervention to cure or treat a disease.
No
Explanation: The device is described as a hearing aid, which is a therapeutic device designed to amplify sound for individuals with hearing loss. Its intended use focuses on addressing existing hearing impairments, not on diagnosing them.
No
The device description explicitly states it is a "bone conduction-type hearing aid" and is "connected to a fixture pillar, which has been surgically placed in the bone". This indicates a physical hardware component is integral to the device's function.
Based on the provided information, the BAHA Divino is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVDs are devices used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- BAHA Divino Function: The BAHA Divino is a bone conduction hearing aid. It works by transmitting sound through the bone to the inner ear to improve hearing. It does not analyze any biological specimens.
- Intended Use: The intended use describes the patient population and conditions for which the device is intended. The BAHA Divino's intended use is for patients with specific types of hearing loss to improve their ability to hear. This is a therapeutic function, not a diagnostic one based on analyzing biological samples.
Therefore, the BAHA Divino falls under the category of a therapeutic medical device, specifically a hearing aid, rather than an IVD.
N/A
Intended Use / Indications for Use
The BAHA Divino is intended for the following patients and indications:
-
Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone conduction threshold should be better than or equal to 45 dB HL (measured at 0.5, 1, 2 and 3 kHz)
-
Bilateral fitting of the Divino is intended for patients who suffer from moderate to severe bilateral symmetric conductive and/or mixed hearing losses. Symmetric bone conductive thresholds are defined as less than 10 dB in average (measured at 0.5, 1, 2 and 4 kHz) or less than 15 dB at individual frequencies
-
The single sided deafness (SSD) indication for the Divino hearing aid is intended for patients who suffer from unilateral sensorineural deafness on one ear while the other ear has normal hearing. Normal hearing is defined as PTA AC threshold equal to or better than 20dB measured at 0.5, 1, 2 and 3 kHz
BAHA for SSD is also indicated for patients who are indicated for an AC CROS but who for some reason cannot or will not use an AC CROS.
Product codes (comma separated list FDA assigned to the subject device)
LXB
Device Description
The BAHA Divino is a bone conduction-type hearing aid. Unlike conventional hearing aids, which depend on acoustic coupling through the air, the Divino is based on a bone conduction technology.
The Divino hearing aid is connected to a fixture pillar, which has been surgically placed in the bone behind the deaf ear. Sound is transmitted through the bones of the skull to the hearing ear with the normal functioning cochlea.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Testing of the BAHA Divino included software validation and functional testing. These tests verify that the Divino is functionally equivalent to the BAHA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K955713, K984162, K011438 and K021837
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.
Not Found
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).
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
1042017
AUG 2 6 2004
SECTION 0. SUMMARY AND CERTIFICATION
A. 510(K) SUMMARY
Summary of Safety and Effectiveness
| SUBMITTER'S NAME: | Entific Medical Systems |
|---|---|
| ADDRESS: | P:O: Box 16024 |
| SE-412 21 G\u00f6teborg | |
| Sweden | |
| CONTACT PERSON: | Constance Bundy |
| TELEPHONE NUMBER: | 763-574-1976 |
| FAX NUMBER: | 763-574-2437 |
| DATE OF SUBMISSION: | July 26, 2004 |
1. Identification of device
Proprietary Name: BAHA Divino® Common Name: Hearing Aid, Bone Conduction Classification Status: Class II per regulations 21 CFR & 874.3300 Product Codes: LXB
2. Equivalent devices
Entific Medical Systems believes that the BAHA Divino has substantially equivalent technology as air conduction hearing aids with digital sound processing (exempt from 510(k)) and, regarding intended use, function and fitting procedure, is equivalent to previous models of BAHA cleared in 510(k) K955713, K984162, K011438 and K021837.
3. Description of the Device
The BAHA Divino is a bone conduction-type hearing aid. Unlike conventional hearing aids, which depend on acoustic coupling through the air, the Divino is based on a bone conduction technology.
The Divino hearing aid is connected to a fixture pillar, which has been surgically placed in the bone behind the deaf ear. Sound is transmitted through the bones of the skull to the hearing ear with the normal functioning cochlea.
1
4. Intended use
The BAHA Divino is intended for the following patients and indications:
-
Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone conduction threshold should be better than or equal to 45 dB HL (measured at 0.5, 1, 2 and 3 kHz)
-
Bilateral fitting of the Divino is intended for patients who suffer from moderate to severe bilateral symmetric conductive and/or mixed hearing losses. Symmetric bone conductive thresholds are defined as less than 10 dB in average (measured at 0.5, 1, 2 and 4 kHz) or less than 15 dB at individual frequencies
-
The single sided deafness (SSD) indication for the Divino hearing aid is intended for patients who suffer from unilateral sensorineural deafness on one ear while the other ear has normal hearing. Normal hearing is defined as PTA AC threshold equal to or better than 20dB measured at 0.5, 1, 2 and 3 kHz
BAHA for SSD is also indicated for patients who are indicated for an AC CROS but who for some reason cannot or will not use an AC CROS.
2
న్. Technological characteristics, comparison to predicate device.
Comparison table
| Characteristic | BAHA -Branemark
Bone Anchored
Hearing aid | Air conduction
Hearing Aids with
digital sound
processing | BAHA Divino |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|----------------------------|
| Material | Implant: Titanium
Abutment Snap:
PEEK | Multiple | Same as BAHA |
| Intended use | Improvement of
hearing for patients
with conductive and
mixed hearing losses,
bilateral fitting and
single sided deafness | Improvement of
hearing | Same as BAHA |
| Power
requirement | Zinc-air | N/A | Same as BAHA |
| Max gain | 33dB | N/A | Same as BAHA |
| Frequency
response | 125 Hz - 8 KHz | N/A | Same as BAHA |
| Sound
processing | Analogue | Digital | Digital |
| Manufacturer | Entific Medical
Systems | N/A | Entific Medical
Systems |
| K-number | K955713, K984162,
K011438 and
K021837 | Exempt | Pending |
6. Discussion of testing
Testing of the BAHA Divino included software validation and functional testing. These tests verify that the Divino is functionally equivalent to the BAHA.
7. Conclusion
It is the conclusion of Entific Medical Systems that the BAHA Divino with digital sound processing is substantially equivalent to devices already on the market, both cleared by and exempt from the 510(k) process, and presents no new concerns about safety and effectiveness.
:
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.
Public Health Service
Food and Drug Administration Rockville MD 20857
AUG 2 6 2004
Entific Medical Systems c/o/ Ms. Constance Bundy C.G. Bundy Associates, Inc. 6740 Riverview Terrace Minneapolis, MN 55432
Re: K042017
Trade/Device Name: BAHA Divino® Regulation Number: 21 CFR 874.3300 Regulation Name: Bone Conduction Hearing Aid Regulatory Class: Class II Product Code: LXB Dated: July 26, 2004 Received: July 27, 2004
Dear Ms. Bundy:
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.
4
Page 2 - Ms. Constance Bundy
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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A kalgi korenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
B. INDICATIONS FOR USE
Koy 2017 510(k) Number
Device Name: BAHA Divino®
Indications for Use:
The BAHA Divino is intended for the following patients and indications:
-
Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone conduction threshold should be better than or equal to 45 dB HL (measured at 0.5, 1, 2 and 3 kHz)
-
Bilateral fitting of the Divino is intended for patients who suffer from moderate to severe bilateral symmetric conductive and/or mixed hearing losses. Symmetric bone conductive thresholds are defined as less than 10 dB in average (measured at 0.5, 1, 2 and 4 kHz) or less than 15 dB at individual frequencies
-
The single sided deafness (SSD) indication for the Divino hearing aid is intended for patients who suffer from unilateral sensorineural deafness on one ear while the other ear has normal hearing. Normal hearing is defined as PTA AC threshold equal to or better than 20dB measured at 0.5, 1, 2 and 3 kHz
BAHA for SSD is also indicated for patients who are indicated for an AC CROS but who for some reason cannot or will not use an AC CROS.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use -------
Kaiser Schlin
510(k) Number K042017