← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K962228 # MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT (K962228) _Ototech Intl., Inc. · ESD · Aug 28, 1996 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K962228 ## Device Facts - **Applicant:** Ototech Intl., Inc. - **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md) - **Decision Date:** Aug 28, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.3300 - **Device Class:** Class 1 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Intended Use The Ototech International Model Alpha Behind-The-Ear Hearing Instrument is intended for use by individuals with Moderate or Mild to Severe hearing loss. ## Device Story Linear behind-the-ear (BTE) hearing aid; captures ambient sound via microphone; processes signal through internal electronics; outputs amplified sound to user ear canal. Housed in custom acrylic plastic case; features single volume wheel control; no potentiometers. Used by patients with hearing loss to improve auditory perception. Device operates via zinc-air battery; provides maximum SSPL90 of 122 dB SPL; reference test gain of 43 dB SPL. No special fitting systems required. ## Clinical Evidence Bench testing only; performance data provided per ANSI S3.22-1987 standards including SSPL90, gain, frequency range, and total harmonic distortion. ## Technological Characteristics Linear BTE hearing aid; custom acrylic plastic case; zinc-air battery (size 675); frequency range 200-5800 Hz; max SSPL90 122 dB SPL; reference test gain 43 dB SPL; ANSI S3.22-1987 compliant. ## 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 - Starkey SM PC - Starkey SM Vega - Bosch Star 22 ## 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} 510(k) SUMMARY K 962228 # OTOTECH INTERNATIONAL MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENTS. ## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared David A. Hough Ototech International Incorporated 3400 N.W. 56 Oklahoma City, Oklahoma 73112 Contact Person: Same as above Date Prepared: 5/20/96 ## Name of device and Name/Address of Sponsor Model Alpha Behind-The-Ear Hearing Instruments Ototech International Inc. 3400 N.W. 56 Oklahoma City, Oklahoma 73112 ## Classification Name The Model Alpha Behind-The-Ear Hearing Instrument is among those devices commonly referred to as air conduction hearing aids. The devices have been classified by the Ear, Nose and Throat Classification Panel as Class I devices set forth in 21 CFR 874.3300. ## Predicate Devices Starkey SM PC Starkey SM Vega Bosch Star 22 {1} # Proposed Labels, Labeling and Advertisements Sufficient to Describe the Device, its Intended Use and the Directions for its Use. Included in this submission are the proposed labeling for the Ototech International Model Alpha Behind-The-Ear Hearing Instrument. This includes the User Instruction Booklet (Appendix A), Label Specifications (Appendix B), Product Specification/Fitting Information (Appendix C), and Substantially Equivalent Devices (Appendix D). ## Intended Use The Ototech International Model Alpha Behind-The-Ear Hearing Instrument is intended for use by individuals with Moderate or Mild to Severe hearing loss. ## Product Description The Model Alpha is a linear hearing device. The electronics for this hearing instrument are contained in a custom acrylic plastic case. The device has one user control - the volume wheel, and no potentiometers. The device does not require any special fitting systems. The acoustical output of the Ototech Model Alpha is a maximum SSPL90 of 122 dB SPL (ANSI S3.22, 1987). The reference test gain is 43 dB SPL. ## Technological Characteristics and Substantial Equivalence Ototech Alpha Behind-the-Ear Hearing Instrument Data according to ANSI S3.22-1987 1. Electrical and Acoustical Data | SSPL90 maximum output | 122 dBSPL | | --- | --- | | HF average SSPL90 | 121 dBSPL | | HF average full-on gain | 50 dBSPL | | Reference test gain | 43 dBSPL | | Equivalent input noise | 25 dBSPL | | Frequency range | 200-5800 Hz | | --- | --- | | T.H.D. at 500 Hz | 5 % | | T.H.D. at 800 Hz | 5 % | | T.H.D. at 1600 Hz | 3 % | | Battery Size | 675 | | --- | --- | | Battery Type | Zinc-air | | Battery current drain | .9 mA | | Typical battery life | 600hrs | {2} The three predicate devices listed above are also linear devices having similar maximum output ranging from 118 to 127dB SPL, and similar gain ranging from 33 to 45dB SPL. The Starkey SM Vega has no potentiometers. The Bosch Star 22 has a tone potentiometer. The Starkey SM PC has one output and one tone potentiometer. --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K962228](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K962228) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com