← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K961082 # TECHNA TONE (K961082) _Techna Tone · ESD · May 7, 1996 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K961082 ## Device Facts - **Applicant:** Techna Tone - **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md) - **Decision Date:** May 7, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.3300 - **Device Class:** Class 1 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Indications for Use 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. ## Device Story Air conduction hearing aid; custom-molded polymer monomer resin shell; contains microphone, amplifier, power source, volume control, and receiver. Manufactured by TECHNA TONE; assembled based on impressions from licensed dispensers or audiologists. Device amplifies sound for hearing-impaired users. Final product verified via ANSI S3.22-1987 electrical integrity testing. Shipped to licensed dispensers/audiologists for final fitting and delivery to end users. ## Clinical Evidence Bench testing only; ANSI S3.22-1987 strip testing performed to verify electrical component integrity. ## Technological Characteristics Air conduction hearing aid; custom shell made of polymer monomer resin; standard electronic components (microphone, amplifier, power source, volume control, receiver). Testing standard: ANSI S3.22-1987. ## Regulatory 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. ## Predicate Devices - Active Electronics hearing aids (post-amendment) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K961082 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: 1. TECHNA TONE USER'S MANUAL 2. Product Profile 3. ANSI Strip 4. 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 device, 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. --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K961082](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K961082) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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