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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the TransEAR™ Bone Conduction Hearing Aid, asserting substantial equivalence to predicate devices rather than providing a detailed study with acceptance criteria and device performance metrics. Such a submission focuses on demonstrating that a new device is as safe and effective as an already legally marketed device (predicate device) and does not typically include novel clinical studies with specific performance targets.

Therefore, many of the requested details about acceptance criteria, detailed study design, sample sizes, expert qualifications, and specific performance metrics are not present in this type of regulatory document. The "study" here is essentially functional testing comparing the new device to existing ones.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of quantitative acceptance criteria or specific discrete performance metrics. Instead, "substantial equivalence" is the overarching acceptance criterion, evaluated based on intended use, function, design, materials, and performance compared to predicate devices. The "reported device performance" is a qualitative statement that "Results of this testing indicate that the TransEAR™ is substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not explicitly stated. The document refers to "Functional testing" but does not detail the size of any test set (e.g., number of participants, amount of data) or the data provenance. In a substantial equivalence claim for a hearing aid, functional testing would likely involve technical performance measurements against industry standards or predicate device specifications, rather than a clinical trial with a large human test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable and not provided. "Ground truth" in the context of this 510(k) is about demonstrating engineering and functional equivalence rather than clinical diagnostic accuracy requiring expert panel review.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable and not provided. Adjudication methods are typically used in studies where there is subjective interpretation of data (e.g., medical image analysis) to establish a consensus ground truth. This is not described for the functional testing.

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, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed or is relevant here.

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

Not applicable in the AI sense. The device itself is a standalone functional device. The "functional testing" refers to the device's technical specifications and operation, not an algorithm's performance in isolation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically discussed in diagnostic accuracy studies (e.g., pathology for imaging algorithms) is not directly applicable here. For a functional hearing aid, "ground truth" in the context of its performance would be established by objective measurements against established engineering and audiological standards. The document states that "Functional testing... was conducted. Results of this testing indicate that the TransEAR™ is substantially equivalent to the predicate devices." This implies comparison to the known performance of predicate devices and relevant standards.

8. The sample size for the training set

Not applicable. This is a conventional medical device, not an AI/machine learning algorithm requiring a "training set."

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

Not applicable. As above, there is no AI training set.

Summary

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K050653

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.

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.

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United Hearing Systems 510(k) Premarket Notification TransEAR™ Bone Conduction Hearing Aid

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Characteristic	TransEAR BoneConductionHearing AidPending	Starkey BC1 BoneConduction CROSHearing AidK923784	Unitron BoneConductionHearing AidK884288	Second Ear BoneConductionHearing AidK953872	BAHAK021837 K042017
510(k) No.	Pending	K923784	K884288	K953872	K021837 K042017
Design	Bone conductionhearing aidconsisting of aprocessor and atransducer(oscillator)connected via asmall wire cable.Vibrator is housedin a standardearmold.	Bone conductionhearing aidconsisting of aprocessor andoscillator.Oscillator isconnected via cordto microphone andamplifier housed ina headband.	Bone conductionhearing aidconsisting of aprocessor andoscillator.Processor isconnected to anoscillator by a cordattached to aheadband.	Bone conductionhearing aidconsisting of aprocessor and aoscillator connectedvia a small wirecable. Theoscillator is heldagainst the skullwith a headband orstrap.	Bone conductionhearing aidconnected to afixture pillar, whichhas been surgicallyplaced in the bonebehind the deaf ear.
Intended Use	To transmit soundthrough the skullbones for hearing.	Same	Same	Same	Same
Indications forUse	Indicated forpersons with singlesided deafness toprovide theperception ofsound from thedeaf ear. Theamplified signal isreceived into thedeaf ear andtransferred throughthe bones of theskull to the bettercochlea.	Indicated forpatients withconductive hearinglosses and normalbone conductionhearing.Particularly usefulfor those withcongenital atresiaand require boneconductionamplification.	Indicated formoderate to severeconductive andmixed hearinglosses that arecomplicated bycongenital oraccidental blockageof air conductionpathways.	Indicated formoderate to severeconductive hearinglosses. Particularlyuseful forconductive lossescompounded bycongenital orsecondaryobstruction ofauditory airconductionmechanisms.	The BAHA forsingle sideddeafness (SSD) isindicated forpatients who sufferfrom unilateralsensorineuraldeafness.Transmits soundfrom the deaf sidethrough the bonesin the skull to thenormal functioningcochlea and isintended toimprove speechrecognition.
Materials	Biocompatiblestandard materialsutilized in thehearing healthindustry.	Same	Same	Same	Same
Energy Source	Zinc-Air battery(675, 10A, or 13)	Same	Same	4.8 VDC Nickel-metal- hydriderechargeablebattery	Same

Table 1: Comparison Table

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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.

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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.

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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
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TransEAR™ Bone Conduction Hearing Aid Device Name:

Indications for Use:

(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)

Over the Counter Use:

Amalolt

Division Sign-

510(k) Number

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.