(87 days)
Not Found
No
The summary describes a bone conduction hearing aid and does not mention any AI or ML components or functionalities.
Yes
The device is intended to improve speech recognition and addresses a medical condition (unilateral sensorineural deafness), which aligns with the definition of a therapeutic device.
No
The device is described as a hearing aid intended to improve speech recognition and transmit sound, not to diagnose a condition.
No
The device description explicitly states it is a bone conduction-type hearing aid connected to a surgically placed fixture pillar, indicating it is a hardware device.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BAHA hearing aid is a device that transmits sound through bone conduction to improve hearing in individuals with single-sided deafness. It is a therapeutic device, not a diagnostic test performed on a biological sample.
- Intended Use: The intended use is to improve speech recognition, which is a functional outcome, not a diagnostic determination.
- Device Description: The description details a surgically implanted device that interacts with the bone, not a test kit or instrument for analyzing biological samples.
Therefore, the BAHA hearing aid, as described, falls under the category of a medical device, specifically a hearing aid, and not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The use of BAHA hearing aid for SSD is intended to improve speech recognition.
The single sided deafness (SSD) indication for BAHA 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
LXB
Device Description
The BAHA is a bone conduction-type hearing aid. Unlike conventional hearing aids, which depend on acoustic coupling through the air, the BAHA is based on a bone conduction technology.
The BAHA 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
A clinical study was conducted to establish the benefits of BAHA for SSD including audiometric evaluation of speech perception in noise as well as a subjective questionnaire (APHAB).
Key Metrics
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.
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SECTION 2. 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 Göteborg | |
| Sweden | |
| CONTACT PERSON: | Constance Bundy |
| TELEPHONE NUMBER: | 763-574-1976 |
| FAX NUMBER: | 763-574-2437 |
| DATE OF SUBMISSION: | June 1. 2002 |
1. Identification of device
Proprietary Name: Branemark Bone Anchored Hearing Aid Common Name: BAHA™M Classification Status: Class II per regulations 21 CFR § 874.3300 Product Codes: LXB
2. Equivalent devices
Entific Medical Systems believes that the single sided deafness (SSD) indication for BAHA hearing aid is substantially equivalent regarding intended use to air conduction hearing aids with a CROS unit (exempt from 510(k)). The BAHA device and its fitting procedure is identical to the Branemark BAHA cleared in 510(k) 955713.
3. Description of the Device
The BAHA is a bone conduction-type hearing aid. Unlike conventional hearing aids, which depend on acoustic coupling through the air, the BAHA is based on a bone conduction technology.
The BAHA 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.
4. Intended use
BAHA hearing aid for SSD is intended for patients who suffer from unilateral sensorineural deafness.
BAHA hearing aid transmits the sound from the deaf side through the bones in the skull to the normal functioning cochlea and is intended to improve speech recognition.
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Technological characteristics, comparison to predicate device. ડ.
Comparison table
| Characteristic | BAHA for single
sided deafness
(SSD) | Air conduction
Hearing Aids with
CROS unit | BAHA - Branemark
Bone Anchored
Hearing aid | S/Eq |
|------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------|
| Material | Same as BAHA | Multiple | Implant: Titanium
Abutment Snap:
PEEK | Yes |
| Intended use | Improvement of
hearing and speech
recognition for SSD
patients | Improvement of
hearing and speech
recognition for SSD
patients | Improvement of
hearing for patients
with conductive and
mixed hearing losses | Yes |
| Power
requirement | Same as BAHA | N/A | Zinc-air | Yes |
| Max gain | Same as BAHA | N/A | 33dB | Yes |
| Frequency
response | Same as BAHA | N/A | 125 Hz - 8KHz | Yes |
| Manufacturer | Entific Medical
Systems | N/A | Entific Medical
Systems | |
| Classification
code | LXB | ESD | LXB | |
| K-number | Pending | Exempt | K955713 | |
CROS = Contra-lateral Routing Of Signals
6. Discussion of testing
A clinical study was conducted to establish the benefits of BAHA for SSD including audiometric evaluation of speech perception in noise as well as a subjective questionnaire (APHAB).
7. Conclusion
It is the conclusion of Entific Medical Systems that the BAHA for SSD 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.
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B. TRUTH AND ACCURACY CERTIFICATION, BAHA FOR SINGLE SIDED DEAFNESS
I certify that, in my capacity as Quality and Regulatory Manager, I believe, to the best of my knowledge, that all data and information submitted in this premarket notification are truthful and accurate, and that no material fact has been omitted.
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Fan Callentrat
Quality and Regulatory Manager, Entific Medical Systems
May 24, 2002 Date
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, with flowing lines beneath them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2002
Entific Medical Systems c/o Constance Bundy Regulatory Consultant to Entific Medical Systems C.G. Bundy Associates, Inc. 6740 Riverview Terrace Minneapolis, MN 55432
Re: K021837
Trade/Device Name: BRANEMARK Bone-Anchored-Hearing Aid (BAHA™) for Single Sided Deafness (SSD)
Regulation Number: 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: LXB Dated: June 1, 2002 Received: June 4, 2002
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.
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Page 2 - 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Ralph Rosenthal
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
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B. INDICATIONS FOR USE
510(k) Number K021837
Device Name: The BRÅNEMARK Bone-Anchored-Hearing Aid (BAHATM).
Indications for Use:
The use of BAHA hearing aid for SSD is intended to improve speech recognition.
The single sided deafness (SSD) indication for BAHA 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.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises | |
| 510(k) Number | K021837 |
| Prescription Use (Per 21 CFR 801.109) | |
| OR | |
| Over the Counter Use | |
| Prescription Use (Per 21 CFR 801.109) |
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