(112 days)
Not Found
No
The description explicitly states the device uses "conventional digital hearing aid technology" and there are no mentions of AI, ML, or related terms.
Yes
The device is indicated for persons with single-sided deafness to provide the perception of sound, which qualifies as treating or alleviating a condition.
No
The device is described as a hearing aid, which provides sound perception, not a diagnostic tool used to identify or measure a condition.
No
The device description explicitly states it consists of a processor, transducer, wire cable, and utilizes a battery, all of which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- TransEAR™ Function: The TransEAR™ Bone Conduction Hearing Aid is a device that transmits sound vibrations through the bones of the skull to improve hearing for individuals with single-sided deafness. It interacts directly with the patient's body to provide a therapeutic benefit (improved hearing perception). It does not analyze samples taken from the body.
The description clearly indicates that the device is a hearing aid that works by bone conduction, which is a form of medical device used for treatment or compensation of a physical impairment, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The TransEAR™ Bone Conduction Hearing Aid is indicated for persons with single sided deafness to provide the perception of sound from the deaf ear. The amplified signal is received into the deaf ear and transferred through the bones of the skull to the better cochlea.
Product codes (comma separated list FDA assigned to the subject device)
LXB
Device Description
TransEAR™ is a bone conduction hearing aid. Unlike conventional air-conduction hearing aids, which depend on acoustic coupling through the air, TransEAR™ utilizes bone conduction technology to transmit sound vibrations through the bones of the skull to the cochlea.
TransEAR™ consists of a processor and a transducer (oscillator) connected via a wire cable. TransEAR's processor uses conventional digital hearing aid technology housed in a conventional behind-the-ear aid housing. The transducer is a mechanical oscillator housed in a conventional ear mold made of standard ear mold material. Each ear mold is custom made from an impression of the wearer's ear. A standard Zinc-Air hearing aid battery is utilized for power.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the skull, cochlea, ear
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)
Functional testing of the TransEAR™ Bone Conduction Hearing Aid was conducted. Results of this testing indicate that the TransEAR™ is substantially equivalent to the predicate devices.
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.
K923784, K884288, K953872, K021837, K042017
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
United Hearing Systems 510(k) Premarket Notification TransEAR™ Bone Conduction Hearing Aid
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IV.
Applicant Name, Address, and Contact: 1.
United Hearing Systems, Inc. 137 Norwich Road Central Village, CT 06332 Tel: (860) 564-4130 Fax: (860) 564-5724 e-mail: rtcampagna@unitedhearing.com
Ralph Campagna Contact:
| Date Prepared: | March 7, 2005 |
|---|---|
| Prepared by: | Melissa Mazzoni |
Identification of the Device 2.
| Proprietary Name: | TransEART™ Bone Conduction Hearing Aid |
|---|---|
| Common Name: | Bone Conduction Hearing Aid |
| Classification: | Class II |
| CFR Section No: | 874.3300 |
| Product Code: | LXB |
Device Description: 3.
TransEAR™ is a bone conduction hearing aid. Unlike conventional air-conduction hearing aids, which depend on acoustic coupling through the air, TransEAR™ utilizes bone conduction technology to transmit sound vibrations through the bones of the skull to the cochlea.
TransEAR™ consists of a processor and a transducer (oscillator) connected via a wire cable. TransEAR's processor uses conventional digital hearing aid technology housed in a conventional behind-the-ear aid housing. The transducer is a mechanical oscillator housed in a conventional ear mold made of standard ear mold material. Each ear mold is custom made from an impression of the wearer's ear. A standard Zinc-Air hearing aid battery is utilized for power.
Technological Characteristic of Substantially Equivalent Device(s): র্বা
The TransEAR™ is substantially equivalent to the following devices:
- Starkey Model BC1 Bone Conduction CROS Hearing Aid a
- Unitron® Bone Conduction Hearing Aid 公
- Second Ear® Bone Conduction Hearing Aid A
- Branemark Bone Anchored Hearing Aid (BAHA) A
- Various behind-the-ear air conduction hearing aids consisting of a digital A sound processor and standard ear mold.
1
United Hearing Systems 510(k) Premarket Notification TransEAR™ Bone Conduction Hearing Aid
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Characteristic | TransEAR Bone
Conduction
Hearing Aid
Pending | Starkey BC1 Bone
Conduction CROS
Hearing Aid
K923784 | Unitron Bone
Conduction
Hearing Aid
K884288 | Second Ear Bone
Conduction
Hearing Aid
K953872 | BAHA
K021837
K042017 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | Pending | K923784 | K884288 | K953872 | K021837
K042017 |
| Design | Bone conduction
hearing aid
consisting of a
processor and a
transducer
(oscillator)
connected via a
small wire cable.
Vibrator is housed
in a standard
earmold. | Bone conduction
hearing aid
consisting of a
processor and
oscillator.
Oscillator is
connected via cord
to microphone and
amplifier housed in
a headband. | Bone conduction
hearing aid
consisting of a
processor and
oscillator.
Processor is
connected to an
oscillator by a cord
attached to a
headband. | Bone conduction
hearing aid
consisting of a
processor and a
oscillator connected
via a small wire
cable. The
oscillator is held
against the skull
with a headband or
strap. | Bone conduction
hearing aid
connected to a
fixture pillar, which
has been surgically
placed in the bone
behind the deaf ear. |
| Intended Use | To transmit sound
through the skull
bones for hearing. | Same | Same | Same | Same |
| Indications for
Use | Indicated for
persons with single
sided deafness to
provide the
perception of
sound from the
deaf ear. The
amplified signal is
received into the
deaf ear and
transferred through
the bones of the
skull to the better
cochlea. | Indicated for
patients with
conductive hearing
losses and normal
bone conduction
hearing.
Particularly useful
for those with
congenital atresia
and require bone
conduction
amplification. | Indicated for
moderate to severe
conductive and
mixed hearing
losses that are
complicated by
congenital or
accidental blockage
of air conduction
pathways. | Indicated for
moderate to severe
conductive hearing
losses. Particularly
useful for
conductive losses
compounded by
congenital or
secondary
obstruction of
auditory air
conduction
mechanisms. | The BAHA for
single sided
deafness (SSD) is
indicated for
patients who suffer
from unilateral
sensorineural
deafness.
Transmits sound
from the deaf side
through the bones
in the skull to the
normal functioning
cochlea and is
intended to
improve speech
recognition. |
| Materials | Biocompatible
standard materials
utilized in the
hearing health
industry. | Same | Same | Same | Same |
| Energy Source | Zinc-Air battery
(675, 10A, or 13) | Same | Same | 4.8 VDC Nickel-
metal- hydride
rechargeable
battery | Same |
Table 1: Comparison Table
2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Functional Testing 5.
Functional testing of the TransEAR™ Bone Conduction Hearing Aid was conducted. Results of this testing indicate that the TransEAR™ is substantially equivalent to the predicate devices.
Conclusion 6.
It is the conclusion of United Hearing System, Inc. that the TransEAR™ Bone Conduction Hearing Aid is substantially equivalent to the predicated devices in terms of intended use, function, design, materials and performance. Additionally, United Hearing Systems concludes that there are no new concerns regarding safety and effectiveness of the device.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 - 2005
United Hearing Systems, Inc. c/o Ralph T. Campagna - CEO 137 Norwich Road Central Village, CT 06332
Re: K050653
Trade/Device Name: TransEAR™ Bone Conduction Hearing Aid Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing aid Regulatory Class: Class II Product Code: LXB Dated: June 23, 2005 Received: June 24, 2005
Dear Mr. Campagna:
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 - Ralph T. Campagna
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) 827-8910. 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/industry/support/index.html.
Sincerely yours,
David M. Whipple
David M. Whipple Acting 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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United Hearing Systems 510(k) Premarket Notification TransEAR™ Bone Conduction Hearing Aid
III. INDICATIONS FOR USE
| 510(k) Number: | K050653 |
|---|---|
| ---------------- | --------- |
TransEAR™ Bone Conduction Hearing Aid Device Name:
Indications for Use:
The TransEAR™ Bone Conduction Hearing Aid is indicated for persons with single sided deafness to provide the perception of sound from the deaf ear. The amplified signal is received into the deaf ear and transferred through the bones of the skull to the better cochlea.
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
(Per 21CFR 801.109)
OR
Over the Counter Use:
Amalolt
Division Sign-
510(k) Number