(166 days)
The InSound XT Hearing Aid is a disposable, extendedwear, air conduction hearing aid, designed to be used and worn by hearingimpaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an ENT physician and it can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal, the hearing aid is discarded.
The InSound XT Series Hearing Device amplifies and delivers sounds via air conduction to the external ear of persons with hearing loss. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. The hearing device is extendedwear (up to 4 months) and disposable. It is placed deep in the ear canal by an ENT physician. The amplification characteristics are contained in digitally programmable memory and adjustment of device parameters is achieved through the proprietary HandFit™ Fitting System and Software.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | |
| Materials contacting skin meet USB Class 6 requirements and pass testing for antimicrobial, cytotoxicity, irritation, and sensitization. | All materials contacting the skin meet USB Class 6 requirements and additionally passed testing for antimicrobial, cytotoxicity, irritation and sensitization. |
| Device with battery assessed as per ANSI C18 Part 1-1999. | The device with its battery has been assessed as per ANSI C18 Part 1-1999 and passed well within the specifications. |
| Efficacy: | |
| Performance characteristics evaluated in accordance with ANSI S3.22-1996, "Specification of Hearing Aid Characteristics." | The devices met all applicable specifications developed by the manufacturer in accordance with test methods outlined in the specifications. |
| Clinical trials confirm comfort, safety, and efficacy for extended wear. | Clinical trials for the InSound XT devices have confirmed that the hearing aids are comfortable, safe and efficacious for wear in human subjects. |
| Clinical trials validate safe and effective use of accessories and fitting system. | Additionally, the clinical trials validated the safe and effective use of the InSound XT accessories and the wireless hand-held fitting system. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the clinical trials or "test set." It only mentions "human subjects." The data provenance is described as "clinical trials" which are typically prospective studies. The country of origin of the data is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical trials. It does mention that the device is "placed deep in the ear canal by an ENT physician," suggesting that ENT physicians would be involved in the clinical setting and potentially in evaluating the device's performance and comfort.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set or clinical trials.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text, nor is there any discussion of an effect size for human readers improving with AI vs. without AI assistance. This is a hearing aid device, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only) performance study was done as this is a physical medical device (hearing aid), not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth for the clinical trials appears to be based on:
- Clinical observations and subject feedback: Assessed comfort, safety, and efficacy during extended wear.
- Hearing aid verification battery: Demonstrated user benefit during extended wear.
- Compliance with ANSI standards: Performance characteristics were evaluated against established engineering specifications.
8. Sample Size for the Training Set
The document does not mention a separate "training set" or its sample size. The clinical trials described appear to serve as the evidence for efficacy and safety.
9. How the Ground Truth for the Training Set was Established
As no separate training set is explicitly mentioned, the establishment of ground truth would refer to how the clinical trial outcomes were determined, as described in point 7.
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NOV 1 9 2002
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | InSound ® Medical, Inc. |
|---|---|
| 37500 Central Court | |
| Newark, CA 94560 USA | |
| Telephone: (510) 792-4000, ext. 445 | |
| Fax: (510) 792-4050 |
| Date of Summary: | June 4, 2002 |
|---|---|
| Revision Date: | November 12, 2002 |
| 2nd Revision Date: | November 18, 2002 |
Legally Marketed Devices To Which Equivalence is Claimed: The legally marketed predicate devices to which equivalence is claimed are:
- The Songbird Disposable Hearing Aid, legally marketed in 2000, after the . exemption of hearing aids from 510(k) Notification, effective February 19, 1998.
- The Decibel Articulate (K964603), determined to be substantially equivalent to a pre-enactment device on December 6, 1996.
- The Philips XP Series (K921725), determined to be substantially equivalent to . a pre-enactment device on August 11, 1992.
Device Description: The InSound XT Series Hearing Device amplifies and delivers sounds via air conduction to the external ear of persons with hearing loss. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. The hearing device is extendedwear (up to 4 months) and disposable. It is placed deep in the ear canal by an ENT physician. The amplification characteristics are contained in digitally programmable memory and adjustment of device parameters is achieved through the proprietary HandFit™ Fitting System and Software.
Intended Use: The InSound XT Hearing Device is a disposable, extended-wear, air conduction hearing aid, designed to be used and worn by hearing-impaired persons. The intended use of the InSound XT Hearing Device is essentially identical to that of the legally marketed predicate devices. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an ENT physician and it can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal, the hearing aid is discarded.
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Descriptive Summary of Technological Characteristics and Those of Predicate Devices: The InSound XT Hearing Device is a disposable, extended-wear, airconduction, programmable hearing aid with a deep canal fitting. It is placed in the ear canal by an ENT physician and it is worn continuously for up to 4 months. The hearing aid's receiver is located deep in the canal, around the second bend, transmitting sound to the tympanic membrane. These characteristics are similar to the Philips XP Series. Amplification characteristics are contained in digitally programmable memory delivered through programming, as with the Decibel Articulate Hearing Aid. The InSound XT Hearing Device is fit to the user with integrated soft retaining seals, like the Songbird Disposable Hearing Aid. Like both the Decibel and Songbird Hearing Aids, the size of the soft retaining seals is selected from a stock of available sizes. The custom battery of the InSound XT Hearing Device is integrated in the device and has a long life. In addition, the hearing aid is discarded when the battery is depleted. Those characteristics are similar to the Songbird Disposable Hearing Aid.
Performance Data: The InSound XT Series hearing device was evaluated for safety and efficacy in the laboratory and in clinical trials with human subjects.
The device has been evaluated to ensure that the long-term residency in the ear canal is safe for the device user. All materials contacting the skin meet USB Class 6 requirements and additionally passed testing for antimicrobial, cytotoxicity, irritation and sensitization.
The device with its battery has been assessed as per ANSI C18 Part 1-1999 and passed well within the specifications.
The performance characteristics of the XT Series hearing aid have been evaluated in accordance with ANSI S3.22-1996, "Specification of Hearing Aid Characteristics". The devices met all applicable specifications developed by the manufacturer in accordance with test methods outlined in the specifications.
Clinical trials for the InSound XT devices have confirmed that the hearing aids are comfortable, safe and efficacious for wear in human subjects. The Clinical results were obtained in three parts: (1) feasibility of the devices in-situ, (2) comfort and long-term wear of the devices and (3) functional device studies which demonstrated user benefit during extended wear via a hearing aid verification battery. Additionally, the clinical trials validated the safe and effective use of the InSound XT accessories and the wireless hand-held fitting system.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2002
InSound Medical, Inc. c/o Susan Whichard 37500 Central Court Newark, CA 94560
Re: K021867
Trade/Device Name: InSound XT Series Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class I Product Code: ESD Dated: September 30, 2002 Received: October 1, 2002
Dear Ms. Whichard:
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 - Susan Whichard
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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Date of submission: June 4. 2002 Date of revision: November 7, 2002
510(k) Number: K021867
. .
Device Name: InSound XT Series Hearing Aid
Indications for Use; The InSound XT Hearing Aid is a disposable, extendedwear, air conduction hearing aid, designed to be used and worn by hearingimpaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an ENT physician and it can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal, the hearing aid is discarded.
Prescription Use _ (Per 21 CFR 801.109)
Karen H. Baker
(Division Sign Off)
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sion of Ophthalmic Ear. Nose and Throat Devises
510(k) Number J
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.