Technology

FDA Authorizes First Over-the-Counter Hearing Aid Software

Published

2 years ago

September 12, 2024

SILVER SPRING, Md., Sept. 12, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones. Once installed and customized to the user’s hearing needs, the Hearing Aid Feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.

“Hearing loss is a significant public health issue impacting millions of Americans,” said Michelle Tarver, M.D., Ph.D., acting director of the FDA’s Center for Devices and Radiological Health. “Today’s marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”

More than 30 million American adults report some degree of hearing loss. Hearing loss can be caused by aging, exposure to loud noises, certain medical conditions, and other factors. Hearing loss can have a negative effect on communication, relationships, school or work performance and emotional well-being. Using hearing aids has been linked to reductions in the frequency or severity of cognitive decline, depression and other health problems in older adults.

The FDA’s OTC hearing aid regulations established in October 2022 represented a significant step toward helping ensure that adults with mild to moderate hearing loss have improved access to more safe and effective product options. The rule enabled consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or seeing an audiologist. Today’s authorization exemplifies the FDA’s continued commitment to provide safe and effective solutions for those with hearing loss, while also fostering innovation and convenience.

The Hearing Aid Feature (HAF) is a software-only mobile medical application that is intended to be used with compatible versions of the AirPods Pro. The HAF utilizes a self-fitting strategy, and users may adjust it to meet their hearing needs without the assistance of a hearing professional. The HAF is set up using an iOS device (e.g., iPhone, iPad), and the user’s hearing levels are accessed from the iOS HealthKit to customize the HAF. Users can refine the volume, tone and balance settings after setting up the HAF.

The HAF was evaluated in a clinical study with 118 subjects with perceived mild to moderate hearing loss, at multiple U.S. sites. The results demonstrated that subjects who used the HAF self-fitting strategy achieved similar perceived benefit as subjects who received professional fitting of the same device. Results also showed comparable performance for tests measuring levels of amplification in the ear canal, as well as a measure of speech understanding in noise. No adverse events related to the device were observed in this study.

This application was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.

As part of the Center for Devices and Radiological Health’s strategic priority to advance health equity, the Center will continue to support innovation that expands access to important technologies and brings health care directly to patients.

The FDA granted marketing authorization of the Hearing Aid Feature to Apple Inc.

Additional Resources:

FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans OTC Hearing Aids: What You Should Know Hearing Aids

Media Contact: Carly (Kempler) Pflaum, 240-672-8872
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration

Technology

eSign.AI Named Sole Electronic Signature Technology Provider for Hong Kong Government’s CorpID Project, Building the Foundation for Digital Signing Infrastructure in Hong Kong

Published

11 hours ago

May 8, 2026

HONG KONG, May 8, 2026 /PRNewswire/ — As Hong Kong’s Digital Corporate Identity Platform (CorpID) counts down to its phased launch, eSign.AI has been appointed as the sole electronic signature vendor in the project, responsible for delivering core digital signing capabilities including digital signatures, certificate management, and signature verification services. CorpID is led by Nexify, a seasoned government systems integrator, as the prime contractor. The platform is expected to launch in phases starting late 2026, with multiple CorpID-based e-government services going live in mid-2027.

CorpID: Government-Grade Digital Identity Infrastructure for Hong Kong Enterprises

The Digital Corporate Identity Platform (CorpID) is an enterprise-level digital services platform launched by the Hong Kong SAR Government, developed under the oversight of the Digital Policy Office (DPO). It is designed to serve as the business equivalent of “iAM Smart,” providing a unified digital identity foundation for Hong Kong enterprises. CorpID’s core mission is to build an integrated digital government infrastructure — offering unified identity authentication, digital signing, form pre-filling, and e-licence storage — replacing paper-heavy, cumbersome traditional processes and enabling smart city development through seamless data connectivity.

The platform is open to companies incorporated under the Companies Ordinance (Cap. 622) and businesses registered under the Business Registration Ordinance (Cap. 310), including sole proprietorships and partnerships. The DPO requires all enterprise-related e-government services to support CorpID within 18 months of launch, and will continue expanding ecosystem coverage through sandbox initiatives, cross-industry identity standard interoperability, and fully online registration processes.

eSign.AI: The Digital Signing Engine Behind CorpID

eSign.AI is an AI-native electronic signature and contract automation platform built for enterprises worldwide, offering a complete signing framework from simple electronic signatures to the highest-level compliant digital signatures — meeting diverse regulatory requirements across industries and jurisdictions.

On the identity verification front, eSign.AI has completed integration with iAM Smart, enabling individual identity verification through Hong Kong’s citizen digital identity system, and providing legally valid digital certificate services for both enterprises and individuals.

Looking ahead, the eSign.AI SaaS platform will be deeply integrated with CorpID, providing enterprise and individual identity verification for Hong Kong businesses, and supporting both electronic and digital signing that complies with Hong Kong’s Electronic Transactions Ordinance — connecting the full digital contracting lifecycle for government and enterprise alike.

Getting Ahead of the AI Era: From eSignGlobal to eSign.AI

The electronic signature industry is undergoing a structural shift from “tooling” to “intelligence.” Market data underscores this acceleration: the AI-powered contract analysis tools market has grown from USD 3.32 billion in 2025 to USD 4.3 billion in 2026, at a CAGR of 29.6%. Signing is just one node in the contract lifecycle — document generation, workflow orchestration, compliance tracking, and post-execution management are all being transformed by AI, and the industry window is closing fast.

In April 2026, the company officially rebranded from eSignGlobal to eSign.AI, completing its strategic transformation from an e-signature tool provider to an AI-native contract automation platform. As the company’s spokesperson noted, this rebrand is not cosmetic — it is an acknowledgment of where the product actually is. Customers were already using eSign.AI to automate workflows that go far beyond the signature itself.

eSign Automation Skill was launched alongside the rebrand — an AI-powered signing automation framework for enterprise workflows that enables complete contract signing through natural language interaction, with no manual intervention required. Whether it is single-party approval, multi-party sequential signing, or large-scale parallel execution, an AI Agent can orchestrate the entire workflow in a single call. All signature initiations and status queries return structured JSON outputs, directly parseable by leading large language models and intelligent workflow systems.

eSign Automation is now available in the OpenClaw ecosystem and supports integration via Claude MCP, ChatGPT, and other leading AI platforms.

By combining AI automation capabilities with CorpID’s government-grade digital identity infrastructure, eSign.AI delivers a complete solution for Hong Kong enterprises — from identity verification to intelligent signing to full workflow automation.

About eSign.AI

eSign.AI (formerly eSignGlobal) is an AI-native electronic signature and contract automation platform built for enterprises worldwide. The platform serves over 100 countries and regions, covering core industries including financial services, manufacturing, real estate, human resources, and healthcare — with 1,500+ scenario applications and 3,000+ ecosystem partners. eSign.AI holds ISO 27001, ISO 27701, and ISO 27018 certifications and supports major regulatory frameworks including the U.S. ESIGN Act / UETA, EU eIDAS, HIPAA, GDPR, and 21 CFR Part 11. Infrastructure is anchored by independent data centers in Hong Kong, Singapore, and Frankfurt, Germany.

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SOURCE eSignGlobal

Technology

The 9th AskGamblers Awards Finalists Announced as Voting Starts

Published

11 hours ago

May 8, 2026

The highly anticipated 9th AskGamblers Awards has officially moved into the voting phase. Following a rigorous selection process, the finalists across 5 premier categories have been revealed: Best Casino, Best New Casino, Best New Slot, Best Sportsbook, Best Provider. Players are invited to cast their votes until 11 June.

BELGRADE, Serbia, May 8, 2026 /PRNewswire/ — The voting stage of the 9th annual AskGamblers Awards has officially begun. The list of finalists is announced, and the first votes are already coming in.

Players will have a chance to vote for their favourites until 11 June, when the winners will be announced at the gala ceremony in Belgrade. There’s a total of 5 categories where popular votes are taken into consideration:

Best CasinoBest New CasinoBest SportsbookBest New SlotBest Game Provider

There aren’t any big changes to the voting process compared to last year. The votes from the prominent members of AskGamblers Forum will be counted in as well, while some award winners will be announced directly by the AskGamblers teams.

These include: Best Crypto Casino, Best Partner, and Best Manager categories, while the AskGamblers Superstar Award is expected to be handed to the operator that illustrates the brand values best.

Dijana Radunović, General Manager at AskGamblers, is excited for voting to start: “We’re seeing some familiar contestants, but there are a lot of new names, so it will be exciting to see who comes up on top.”

“We invite players to vote for their favourites! This is a chance for you to speak your mind and support operators and games that shape this industry,” Radunović added.

Before the AskGamblers Awards Ceremony that takes place on 11 June, Charity Night is scheduled for 10 June.

About AskGamblers

AskGamblers.com strives to provide current, objective, and accurate information and guide its users towards a safe gaming experience. The way we deliver our services, from the online casino, sportsbook, slot, and bonus reviews to our trusted Complaint Service, is best described by our motto: ‘Get the truth. Then play.’

For more information about AskGamblers and AskGamblers Awards, please contact dijana.radunovic@g2m.com.

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Technology

SUNMI Wins 2026 Red Dot Design Awards with Five Products, Leading Global Commercial Industrial Design

Published

11 hours ago

May 8, 2026

SINGAPORE, May 8, 2026 /PRNewswire/ — The winners of the 2026 German Red Dot Design Award were officially announced. Five of SUNMI Technology’s flagship products won awards: the CPad Business Tablet, CPad PAY, FLEX 3 Interactive Display, the V3 handheld POS Terminal and L3 Industrial PDA. These products stood out with three core design concepts: integration, versatility and human-centricity.

Known as “The Oscars” of global industrial design, the Red Dot Award has strict evaluation criteria covering aesthetics, ergonomics, scenario adaptability and sustainability. SUNMI adheres to original commercial scenario customization, rejecting crudely modified consumer devices. All winning products are originally developed for real commercial scenarios such as cash register, food delivery, industrial inspection and store operations, covering the entire commercial track with high scenario adaptability. Meanwhile, it practices ESG concepts, adopting eco-friendly materials and modular structures to extend equipment service life, reduce consumable consumption, and implement low-carbon and long-term design, which perfectly meets the Red Dot’s sustainability evaluation criteria.

Simplify Complexity: With highly integrated design, SUNMI eliminates the “patchwork feeling” of cluttered devices and tangled cables in traditional commercial scenarios, streamlining store operations and saving space.All-in-One Versatility: Beyond a single tool function, SUNMI’s products achieve flexible transformation through modular and multi-form designs to proactively adapt to changing business needs. The CPad series with modular accessories and FLEX 3’s Lego-style modular design enable multi-scenario application and long-term reuse.Human-Centric Design: Every detail is human-oriented, focusing on real pain points to enhance scenario experience. The L3 Industrial PDA reduces high-frequency work fatigue through scientific weight distribution; the V3 Smart POS Terminal balances large-screen visibility and grip comfort; CPad PAY integrates full-link functions to simplify workflows.

These honors stem from SUNMI’s long-term commitment to a sustainable society, original commercial R&D and ESG. In the future, SUNMI will uphold its core concepts, expand the boundaries of commercial industrial design, and empower global businesses with user-oriented, eco-friendly and high-value products.

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