(50 days)
TECHNA TONE intends to manufacture and market three different models of an air conduction hearing aid which will be used to amplify sounds for the hearing impaired.
TECHNA TONE will receive an impression from the licensed dispenser or Audiologist and will mold a custom shell using polymer monomer resin in one of three colors. A microphone, amplifier, power source, volume control, and receiver will be inserted. The components being used are industry standards and are currently used by many other hearing aid manufacturers. The final step of the manufacturing process is to run an ANSI S3.22.1987 strip to verify that the integrity of all electrical components meet the specifications stated.
Here's an analysis of the provided text in the context of acceptance criteria and a study to prove device performance:
Analysis of the Provided Text (K961082):
The provided text, a 510(k) submission summary for TECHNA TONE Hearing Aids, does not contain the information requested regarding acceptance criteria and a study proving device performance using a test set with ground truth.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Active Electronics hearing aids) based on:
- Similar intended use: Amplifying sounds for the hearing impaired.
- Similar technological characteristics: Using the same basic components (microphone, amplifier, power source, volume control, receiver), standard industry components, and manufacturing processes (custom shell molding, ANSI S3.22.1987 strip to verify electrical components).
- No new questions of safety or effectiveness: Stating that differences in component sourcing and assembly location "will not affect the safety or effectiveness of the product."
The core of this submission is a comparison of features to an existing device, not a performance study against predefined acceptance criteria for the new device itself.
Therefore, I cannot populate the requested table and sections with information directly from the provided K961082 submission.
Hypothetical Example of How This Information Would Be Presented if it were Available in the Document:
If the K961082 document did contain the requested information, it might look something like this (this is entirely conjectural and based on typical regulatory submissions for devices requiring performance data):
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|
| Acoustic Performance | |||
| Maximum Output Sound Pressure Level (OSPL90) | Within ±X dB of target (e.g., 120 dB) | 119.5 dB | Pass |
| Full-On Gain (FOG) | Within ±Y dB of target (e.g., 50 dB) | 49.8 dB | Pass |
| Total Harmonic Distortion (THD) | < Z% at specified frequencies (e.g., <5% at 500, 800, 1600 Hz) | 2% @ 500 Hz, 3% @ 800 Hz, 4% @ 1600 Hz | Pass |
| Equivalent Input Noise (EIN) | < A dB SPL (e.g., <25 dB SPL) | 22 dB SPL | Pass |
| Frequency Response | Within ±B dB of target curve | Met target curve within ±1.5 dB | Pass |
| Functional Reliability | |||
| Battery Life (continuous use) | > C hours (e.g., >100 hours) | 105 hours | Pass |
| Volume Control Range | ≥ D dB (e.g., ≥20 dB) | 22 dB | Pass |
| User Safety | |||
| Electrical Safety (IEC 60601-1) | Compliance with standard | Compliant | Pass |
| Biocompatibility (ISO 10993) | Compliance with standard for materials in contact with skin | Compliant | Pass |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: A clinical study involving 50 subjects (e.g., 25 with mild-moderate hearing loss, 25 with moderate-severe hearing loss) would typically be used for real-world performance evaluation. For acoustic performance, a sample of 20 manufactured devices might be tested.
- Data Provenance: Prospective, multi-center clinical study conducted in the USA (e.g., at university audiology clinics in Texas, California, and New York).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: For the clinical performance aspect (e.g., sound quality, speech intelligibility), "ground truth" would often be subjective patient feedback and objective audiological measurements.
- Qualifications: Audiologists (e.g., 3 PhD-level audiologists, each with 10+ years of clinical experience specializing in hearing aid fitting and evaluation) would conduct the objective measurements and assess patient feedback using validated scales.
4. Adjudication method for the test set
- For the objective, quantifiable metrics (acoustic tests), no adjudication beyond standard measurement protocols would be needed.
- For subjective patient feedback (e.g., sound quality, comfort), standardized questionnaires (e.g., APHAB, IOI-HA) would be used, and statistical analysis would determine significance. If multiple audiologists were evaluating a patient's fitting, consensus on parameters might be reached through discussion if discrepancies arose, but formal "adjudication" in the sense of image review is less common.
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
This is not applicable to a hearing aid. MRMC studies are typically used for diagnostic devices (e.g., AI for radiology) where human readers (e.g., radiologists) interpret data with or without AI assistance. A hearing aid is a therapeutic/assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the same way it would be for an AI algorithm. The hearing aid is the standalone device. Its performance is measured directly through acoustic tests and clinical outcomes through use.
7. The type of ground truth used
- Clinical Performance:
- Objective: Gold standard audiological measurements (e.g., pure tone audiometry, speech audiometry, real-ear measurements) performed by licensed audiologists.
- Subjective: Standardized patient self-assessment questionnaires (e.g., APHAB, IOI-HA) and user satisfaction surveys.
- Technical Performance: ANSI S3.22.1987 (or later versions) standards for electroacoustic measurements.
8. The sample size for the training set
- Hearing aids are not typically "trained" in the machine learning sense. The design and parameters are established through engineering principles, acoustic modeling, and extensive component testing.
- If we were to stretch the definition, the "training data" would be the vast body of audiological research, acoustic principles, and engineering data accumulated over decades of hearing aid development. The components themselves have their own "specifications" derived from extensive testing by their manufacturers.
9. How the ground truth for the training set was established
- As above, "training set ground truth" doesn't directly apply here. Instead, it's about established engineering principles and component specifications. For example, a microphone's sensitivity is established by testing it against a known sound pressure level using calibrated equipment. An amplifier's gain is verified using signal generators and voltmeters according to electrical engineering standards.
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TECHNA TONE Hearing Aids 350 N. Belt East #255 Houston, Texas 77060 (713) 820-9393 Fax #(713) 820-9590
MAY -7 1996
FDA 510(K) Submission Summary of Safety & Effectiveness
TECHNA TONE intends to manufacture and market three different models of an air conduction hearing aid which will be used to amplify sounds for the hearing impaired. These devices will produce similar results and will be manufactured using the same industry standards thereby making it substantially equivalent to the post amendment devices currently marketed by Active Electronics. The attached comparison chart highlights the features of both manufacturers products for easy reference.
TECHNA TONE will receive an impression from the licensed dispenser or Audiologist and will mold a custom shell using polymer monomer resin in one of three colors. A microphone, amplifier, power source, volume control, and receiver will be inserted. The components being used are industry standards and are currently used by many other hearing aid manufacturers. The final step of the manufacturing process is to run an ANSI S3.22.1987 strip to verify that the integrity of all electrical components meet the specifications stated.
After manufacture, the completed hearing instrument will be packaged in a polyethylene bag, enclosed inside a 1/2" foam protector and will then be placed in a corrugated cardboard box for shipment to the licensed Dispenser or Audiologist for final delivery to the end user. The outer corrugated box has not reached final development but will contain the following information:
| Manufactured by: | TECHNA TONE |
|---|---|
| 350 N. Belt East #255 | |
| Houston, Texas 77060 |
| Model#: | |
|---|---|
| Serial #: | |
| Customer Name: |
The following inserts will be included in the corrugated box prior to shipment.
-
- TECHNA TONE USER'S MANUAL
-
- Product Profile
-
- ANSI Strip
-
- Warranty Card
Hearing aids are manufactured with 5 basic working components (microphone, amplifier, power source, volume control and receiver) inserted into an outer shell. The proposed TECHNA TONE aid will include these same components and will produce similar results as the predicate dcvice, the only differences are really in the source of the components and the location of assembly. These differences will not affect the safety or effectiveness of the product.
§ 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.