K961082 · Techna Tone · ESD · May 7, 1996 · Ear, Nose, Throat
Device Facts
Record ID
K961082
Device Name
TECHNA TONE
Applicant
Techna Tone
Product Code
ESD · Ear, Nose, Throat
Decision Date
May 7, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 874.3300
Device Class
Class 1
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.
Indications for Use
Indicated for hearing impaired individuals requiring sound amplification via air conduction hearing aids.
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.
Predicate Devices
Active Electronics hearing aids (post-amendment)
Submission Summary (Full Text)
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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.
