K021867 · Insound Medical, Inc. · ESD · Nov 19, 2002 · Ear, Nose, Throat
Device Facts
Record ID
K021867
Device Name
INSOUND XT SERIES HEARING AID
Applicant
Insound Medical, Inc.
Product Code
ESD · Ear, Nose, Throat
Decision Date
Nov 19, 2002
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 874.3300
Device Class
Class 1
Attributes
Therapeutic
Indications for 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.
Device Story
InSound XT Series is a disposable, extended-wear, air conduction hearing aid. Microphone transforms sound waves into electrical signals; hearing aid circuit (powered by integrated battery) amplifies signals; receiver delivers sound to tympanic membrane. Device placed deep in ear canal by ENT physician; worn continuously up to 4 months. Amplification parameters stored in digitally programmable memory; adjusted via proprietary HandFit™ Fitting System and Software. Device discarded upon battery depletion. Benefits include long-term hearing assistance without daily maintenance.
Clinical Evidence
Clinical trials evaluated feasibility, comfort, long-term wear, and functional user benefit via hearing aid verification battery. Trials also validated safety of accessories and the wireless HandFit™ system. Bench testing confirmed compliance with ANSI S3.22-1996 for hearing aid characteristics and ANSI C18 Part 1-1999 for battery safety. All patient-contact materials met USP Class 6 requirements and passed testing for antimicrobial, cytotoxicity, irritation, and sensitization.
Technological Characteristics
Disposable, extended-wear, air-conduction hearing aid. Features deep canal fitting with soft retaining seals. Digitally programmable memory for amplification parameters. Powered by integrated long-life battery. Materials meet USP Class 6 requirements. Tested per ANSI S3.22-1996 (performance) and ANSI C18 Part 1-1999 (battery).
Indications for Use
Indicated for hearing-impaired persons requiring air conduction hearing assistance. Device is placed in the ear canal by an ENT physician for extended wear up to 4 months.
Regulatory Classification
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.
{0}------------------------------------------------
## 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.
{1}------------------------------------------------
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.
{2}------------------------------------------------
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.
{3}------------------------------------------------
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
{4}------------------------------------------------
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)
11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
sion of Ophthalmic Ear. Nose and Throat Devises
510(k) Number J
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
