The Amplaid A756 Screening Admittance Meter can Evaluate middle ear functions such as otitis media, glue ear, eardrum scar tissues, perform myringotomy status, ossicular chain discontinuity ear canal volume, otosclerosis, stapes fixation. Perform Acoustic reflex test. Determine acoustic reflex threshold Perform reflex decay test. The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.
Device Story
Amplaid A756 is a screening admittance meter for clinical assessment of middle ear function. Device measures acoustic impedance to evaluate conditions like otitis media, eardrum scarring, and ossicular chain issues. Performs tympanometry (plane and compensated), acoustic reflex tests, reflex thresholds, and decay measurements. Operated by qualified audiologists in clinical settings. Input involves acoustic stimuli; device processes signals to determine admittance metrics. Output provided via built-in liquid crystal display and thermal printer. RS232 interface allows data connectivity. Device aids clinicians in diagnosing middle ear pathologies and monitoring treatment status, facilitating appropriate patient management.
Clinical Evidence
Bench testing only. No clinical data provided. Safety and effectiveness were established through comparison of technical specifications, performance standards, and user testing against the predicate device.
Technological Characteristics
Admittance meter; 115/230 Vac energy source. Features built-in LCD, keyboard, and thermal printer. Connectivity via RS232. Complies with IEC 61027, ANSI S3.39, IEC 60645-1, ANSI S3.6, and EN ISO 389. Electrical safety per EN 60601-1 Class I Type B. Dimensions: 14" x 11" x 7"; Weight: 7.7 lbs.
Indications for Use
Indicated for adult and pediatric patients requiring evaluation of middle ear function (e.g., otitis media, otosclerosis, stapes fixation, ossicular chain discontinuity) and acoustic reflex testing.
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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# KO31978
JUL 2 1 2003
#### EXHIBIT 2 Amplaid -Biomedical division of Amplimedical S.p.A. (Amplifon Group) Via Donizetti. 12 - 20090 Assago - Milan (Italy) Tel. +39 02 45790303 +39 02 45790340 Fax. Contact: Giovanni Rollier, CEO June 24, 2003
### 510(k) Summary of Safety and Effectiveness
- 1. Identification of the Device: Proprietarv-Trade Name: Amplaid A756 Classification Name: Auditory Impedance Tester 77ETY Common/Usual Name: Admittance Meter
- 2. Equivalent legally marketed devices This product is similar in design and function to the AMPLAID A724 and A728 ADMITTANCE METERS (K992370)
- 3. Indications for Use (intended use) The Amplaid A756 Screening Admittance Meter can
- Evaluate middle ear functions such as otitis media, glue ear, eardrum scar tissues, perform . myringotomy status, ossicular chain discontinuity ear canal volume, otosclerosis, stapes fixation.
- Perform Acoustic reflex test. .
- . Determine acoustic reflex threshold
- Perform reflex decav test. .
The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.
- 4. Description of the Device: The Amplaid A756 Screening ADMITTANCE METER performs plane and compensated tympanometry; Programmed and manual stimuli for ipsilateral and contralateral acoustic reflex; Automatic reflex threshold; and Decay measurements.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate device.
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# 6. Substantial Equivalence Chart
| Characteristic | Predicate K992370<br>Amplaid A724 –A728 | Amplaid A756 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Clinical auditory impedance<br>testing applications | Screening audiometry impedance<br>testing applications |
| Technical characteristics | | |
| Physical characteristics: | | |
| Computer interface | RS232 Bi-directional | SAME |
| Display | Built-in liquid crystal | SAME |
| Control interface | Built-in keyboard | SAME |
| Size/weight | 19.6"w x 16"d x 8"h<br>18.8 lbs. | 14' x 11" x 7"<br>7.7 lbs. |
| Energy Source: | 115/230 Vac, ± 10%, 50-60 Hz<br>(100 va) | SAME (40 va) |
| Hardcopy Output: | Built-in Thermal printer | SAME |
| Standards and Safety characteristics: | | |
| Audiometric: | Performance Standards<br>IEC 61027 (1993); Instruments<br>for the measurement of aural<br>acoustic impedance/admittance<br>ANSI S3.39(1987): Specifications<br>for Instruments to Measure Aural<br>Acoustic Impedance and<br>Admittance (Aural Acoustic<br>Immittance);<br>IEC 60645-1: Audiometers - Part<br>1: Pure-tone audiometers<br>ANSI S3.6 (1996): Specification<br>for audiometers;<br>EN ISO 389 (1995): Acoustics –<br>Standard reference zero for the<br>calibration of pure-tone air<br>conduction audiometers | SAME |
| Electrical safety: | EN 60601-1 Class I Type BF<br>(1990);<br>EN 60601-1/A1 (1993);<br>EN 60601-1/A2 (1995);<br>EN 60601-1/A13 (1996)<br>EMC: EN 60601-1-2 (1993) | EN 60601-1 Class I Type B<br>(1990);<br>EN 60601-1/A1 (1993);<br>EN 60601-1/A2 (1995);<br>EN 60601-1/A13 (1996)<br>EMC: EN 60601-1-2 (1993) |
#### 7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of Amplaid. that the Amplaid A756 is safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the border. Inside the circle is a symbol that resembles an eagle with three lines representing its wings. The seal appears to be a logo or emblem for the U.S. Department of Health and Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2003
Amplaid c/o Daniel Kamm, P.E. Regulatory Engineer P.O. Box 7007 Deerfield. IL 60015
Re: K031978
Trade/Device Name: Amplaid A756 Screening Admittance Meter Regulation Number: 21 CFR 874.1090 Regulation Name: Auditory impedance tester Regulatory Class: Class II Product Code: ETY Dated: June 24, 2003 Received: June 26, 2003
Dear Mr. Kamm:
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 - Daniel Kamm, P.E.
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) 594-4613. 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/dsma/dsmamain.html
Sincerely yours.
Alegi 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
Enclosure
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# j) Indications for Use
510(k) Number_ KO 31978
Device Name: Amplaid A756 Screening Admittance Meter
Indications for Use: The Amplaid A756 Screening Admittance Meter can
- I . Evaluate middle ear functions such as otitis media, glue ear, eardrum scar tissues, perform myringotomy status, ossicular chain discontinuity ear canal volume, otosclerosis, stapes fixation.
- 2. Perform Acoustic reflex test.
- 3. Determine acoustic reflex threshold
- 4. Perform reflex decay test.
The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K031975 |
|---------------|---------|
|---------------|---------|
| Prescription Use | <div> <img alt="Tick" src="tick.png"/> </div> | OR | Over the Counter Use |
|------------------|-----------------------------------------------|----|----------------------|
| | | | (Per 21 CFR 801.109) |
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Learn the FDA Browser
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.
