K994254 · International Distributors of Electronics For Medi · ETY · Mar 14, 2000 · Ear, Nose, Throat
Device Facts
Record ID
K994254
Device Name
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
Applicant
International Distributors of Electronics For Medi
Product Code
ETY · Ear, Nose, Throat
Decision Date
Mar 14, 2000
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 874.1090
Device Class
Class 2
Indications for Use
The Interacoustics AT235 Impedance Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.
Device Story
The Interacoustics AT235 is an electroacoustic diagnostic instrument used by clinicians to evaluate hearing and otologic function. It generates controlled test tones and signals delivered via transducers (TDH39 contralateral earphone and probe). The device performs tympanometry, acoustic reflex testing, and air conduction audiometry. Input data includes patient response via a handheld push-button switch. The device processes these inputs to provide diagnostic measurements, which are displayed digitally. It supports connectivity to Windows-based software (IABase95, Printview, IA-NOAH-IMP) for monitoring, printing, and database integration. The output assists clinicians in diagnosing otologic disorders. The device is intended for clinical use.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing and compliance with safety and performance standards, including ANSI S3.39-1987, IEC 1027-1991, ANSI 3.6-1989, IEC 645-1-1992, and IEC 601-1-1988.
Technological Characteristics
Electroacoustic impedance audiometer. Materials: TDH39 transducers, probe with probe tip. Energy: 100-120V or 220-240V AC. Standards: ANSI S3.39-1987 (Impedance), IEC 1027-1991 (Impedance), ANSI 3.6-1989 (Audiometer), IEC 645-1-1992 (Audiometer), IEC 601-1-1988 (Safety). Connectivity: PC interface via Windows software (IABase95, IA-NOAH-IMP). Form factor: 14" x 10" x 4", 6 lbs.
Indications for Use
Indicated for patients requiring diagnostic hearing evaluations and assessment of otologic disorders via tympanometry, acoustic reflex, and air conduction audiometry.
Regulatory Classification
Identification
An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.
Special Controls
*Classification.* Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
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K994254/
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| MAR 1 4 2000 | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| 510(k) SUMMARY | |
| PREPARED BY: | INTERNATIONAL DISTRIBUTORS OF<br>ELECTRONICS FOR MEDICINE, INC.<br>(IDEM)<br>4814 East Second Street<br>Benicia, CA 94510 |
| CONTACT PERSON: | Donna Ward, President |
| TELEPHONE: | 800-947-6334 |
| DATE ON WHICH THE SUMMARY<br>WAS PREPARED: | December 14,1999 |
| NAME OF DEVICE: | Interacoustics AT235<br>Impedance Audiometer |
| COMMON NAME: | Impedence Audiometer |
| PREDICATE DEVICE: | Interacoustics Impedance Audiometer |
DESCRIPTION OF DEVICE:
The Interacoustics AT235 Impedence Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.
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## Comparison of the Interacoustics Model AT235 Impedance Audiometer and The Interacoustics AT22t Automatic Impedance Audiometer.
Indication for use - Identical for both units.
Similarities and differences:
| Interacoustics AT235 | Interacoustics AT22t Automatic |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Impedance Audiometer | Impedance Audiometer |
| Display Description: Digital | Digital |
| Available Frequencies: | |
| 125 Hz, 250 Hz, 500 Hz, 1kHz, 2kHz,<br>3kHz, 4kHz, 6kHz, and 8kHz | 250 Hz, 500 Hz, 1kHz, 2kHz, 3kHz,<br>4kHz, 6kHz, and 8kHz |
| Probe Tone Frequency: 226Hz ± 3% | Same |
| Probe Tone Intensity: 85dB SPL ± 3dB | Same |
| Pressure Range: +300 to -600daPa | +200 to -300daPa |
| Compliance Range: 0,1 to 5 ml | Same |
| Transducers: TDH39 Single<br>Contralateral Earphone, Probe with<br>Probe Tip | Same |
| Patient response unit: Handheld Push<br>Button Switch | Same |
| Compatible Windows Software:<br>IABase95 Database program, Printview<br>for On-line PC Monitoring and Printing,<br>IA-NOAH-IMP Module for Interfacing<br>to NOAH | Same |
| Tests: Tympanometry, Acoustic Reflex<br>and Air Conduction Audiometry | Same |
| Calibration: Impedance: ANSI S 3.39-<br>1987, IEC 1027-1991 | |
| Audiometer: ISO/R 389-1991 | Same |
| Power: 100-120 V or 220-240V | Same |
| Size and Weight: 14" x 10" x 4"; 6 lbs. | 14" x 16" x 6"; 15.5 lbs. |
## SAFETY AND EFFECTIVENESS:
The Interacoustics AT235 Impedance Audiometer is in compliance with the following performance and safety standards:
Audiometer: ANSI 3.6- 1989 IEC 645-1-1992 Type 4 Impedance: ANSI 3.39-1987 IEC 1027-1991 Type 2 Safety: IEC 601-1-1988
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized graphic of a bird-like figure, possibly representing an eagle, with three curved lines forming its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
## MAR 1 4 2000
Ms. Donna Ward President International Distributors of Electronics For Medicine, Inc. (IDEM) 4814 East Second Street Benicia, CA 94510
Re: K994254 Trade Name: Interacoustics AT235 Impedance Audiometer Regulatory Class: II CFR: 874.1090 Product Code: 77ETY Dated: December 15, 1999 Received: December 17, 1999
Dear Ms. Ward:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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## Page 2 - Ms. Donna Ward
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K994254 |
|---------------------------|---------|
|---------------------------|---------|
Interacoustics Model AT235 Impedance Audiometer Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Usc:
The Interacoustics AT235 Impedance Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Over-The-Counter Use_ OR Prescription Use (Pcr 21 CFR 801.109) Sign-Off)
is on of Ophthalmic
510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Formal 1-2-96)
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.
