About Acevion โ€” Affordable FDA-Registered OTC Hearing Aids

About Acevion

Free Your Ears, Feel the World. Acevion is a hearing health brand dedicated to making professional-grade, FDA-registered OTC hearing aids accessible to everyone โ€” without the $2,000+ price tag of traditional audiology channels.

Our Mission

Over 37.5 million American adults experience some degree of hearing loss (NIDCD, 2023). Yet the average cost of a professionally fitted hearing aid pair exceeds $4,700, placing clear hearing out of reach for millions of seniors and adults on fixed incomes.

Acevion was built to change that. We develop rechargeable, discreet, and easy-to-use OTC hearing aids that deliver DSP-powered sound clarity at a fraction of the traditional cost โ€” no prescription required under the FDA OTC Hearing Aid Final Rule (October 2022).

Product Credentials & Quality Standards

๐Ÿ›๏ธ FDA Registration

All Acevion hearing aids are FDA-registered OTC hearing aids under 21 CFR Part 800, compliant with the FDA's October 2022 OTC Hearing Aid Final Rule. Our devices meet federal safety and performance standards for adults with mild to moderately severe hearing loss (26โ€“70 dB HL) and are classified as Class II medical devices โ€” distinct from unregulated personal sound amplifiers (PSAPs).

Verify OTC hearing aid regulations: FDA.gov โ€” OTC Hearing Aids: What You Should Know

โš™๏ธ DSP Technology Specifications

Specification Acevion Standard Typical Budget Amplifier
Signal Processing Channels 16โ€“24 channels 2โ€“4 channels
Noise Cancellation Adaptive DSP noise filtering None
Feedback Suppression Automatic feedback reduction None
Water Resistance IP54 rated (sweat & splash proof) None
Battery Life 19h use + 60h charging case 8โ€“12h (disposable battery)
Volume Modes 4โ€“6 preset listening modes 1 (volume dial only)
Output Limiting Yes โ€” FDA-required hearing protection No
Regulatory Status FDA-registered Class II medical device Unregulated consumer product

๐Ÿ›ก๏ธ Safety & Quality Assurance

  • IP54 ingress protection โ€” tested against sweat, moisture, and splash (IEC 60529 standard)
  • Medical-grade silicone ear domes โ€” hypoallergenic, skin-safe materials certified for extended wear
  • Output limiting circuit โ€” prevents over-amplification in compliance with FDA OTC hearing aid maximum output requirements
  • ISO-certified manufacturing โ€” produced in facilities meeting international quality management standards
  • Multi-size fit system โ€” S/M/L ear domes included to accommodate varied ear canal anatomies

๐Ÿ”ฌ Hearing Loss Coverage

Acevion OTC hearing aids are designed and tested for:

  • Mild hearing loss (26โ€“40 dB HL) โ€” difficulty hearing soft speech and high-frequency sounds
  • Moderate hearing loss (41โ€“55 dB HL) โ€” difficulty hearing conversational speech at normal distances
  • Moderately severe hearing loss (56โ€“70 dB HL) โ€” difficulty hearing even loud speech

Not suitable for: severe (>70 dB HL) or profound hearing loss, single-sided deafness, or hearing loss due to medical conditions requiring physician evaluation. Source: WHO Hearing Loss Grades

Our Products

Every Acevion hearing aid is engineered around three principles:

  • Clinical-grade technology โ€” 16โ€“24 channel DSP chips, adaptive noise cancellation, and feedback suppression
  • Comfort-first design โ€” multiple ear dome sizes, ultra-lightweight form factors (ITE, BTE, neckband), and rechargeable batteries with 19+ hour life
  • Regulatory compliance โ€” all devices are FDA-registered OTC hearing aids meeting federal safety standards

Our lineup: ITE in-ear (D22) ยท BTE behind-the-ear (507) ยท Bluetooth neckband (7018) ยท ITE 2.1

Company Background

Acevion is a global hearing health company with R&D operations in Hong Kong and manufacturing through an ISO-certified supply chain โ€” the same manufacturing ecosystem trusted by leading consumer electronics brands worldwide. By selling direct-to-consumer, we eliminate the audiologist markup and retail overhead that account for the majority of traditional hearing aid costs.

Acevion devices are sold in the United States via our official website and Amazon. All products ship from US-based fulfillment centers for fast delivery.

Our Commitment

  • ๐Ÿ’ฐ From $99 โ€” 95% less than traditional hearing aid channels
  • ๐Ÿ”„ 7-day money-back guarantee
  • ๐Ÿ›ก๏ธ 1-year limited warranty on all devices
  • ๐Ÿšš Free fast shipping on every US order
  • ๐Ÿ“ž Customer support: support@acevion.com

Sources: NIDCD Hearing Statistics (2023) ยท FDA OTC Hearing Aid Final Rule (2022) ยท WHO Grades of Hearing Impairment ยท IEC 60529 IP Rating Standard

Learn More About Hearing Health

At Acevion, we believe informed decisions lead to better hearing outcomes. Explore our comprehensive guides: