• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to secondary sidebar
  • Skip to footer

  • Opinion
  • Health IT
    • Behavioral Health
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Patient Engagement
    • Population Health Management
    • Revenue Cycle Management
    • Social Determinants of Health
  • Digital Health
    • AI
    • Blockchain
    • Precision Medicine
    • Telehealth
    • Wearables
  • Life Sciences
  • Investments
  • M&A
  • Value-based Care
    • Accountable Care (ACOs)
    • Medicare Advantage

Bose Launches First FDA-Cleared DTC Hearing Aids

by Jasmine Pennic 05/12/2021 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

What You Should Know:

– Bose is entering the digital health market launch of Bose SoundControl Hearing Aids – the first FDA-cleared, direct-to-consumer hearing aid.   

– Weighing 3 grams each, the new SoundControl™ Hearing Aids are developed for adults with perceived mild to moderate hearing loss. Eight batteries are included in total, and one lasts up to four days when used 14 hours daily. They can be replaced wherever hearing aid batteries are sold and easily changed via a durable door on the exterior.

– Paired with the revolutionary Bose Hear app, users can fit, program, and control a SoundControl Hearing Aid for clinically proven, audiologist-quality results — without a doctor visit, hearing test, or prescription. And they can make setting adjustments themselves, in real-time and real-world environments, without assistance from a healthcare professional.

Clinical Study Outcomes/Results

In a clinical study with researchers at Northwestern University, Bose CustomTune technology yielded results that were as good if not better than those achieved by traditional prescription-fitting methods used by audiologists. The study’s participants were split into two groups with similar levels of hearing loss. One group used Bose CustomTune technology to self-tune a device, the other had the same device fit and tuned by an audiologist. Participants using Bose CustomTune technology reported being more satisfied with their sound quality than those whose devices were tuned by a hearing health professional.

Pricing & Availability

SoundControl Hearing Aids come with a 90-day risk-free trial, dedicated product support, and are available at a fraction of the cost of most conventional hearing aids. They will be sold directly from Bose for $849.95 starting May 18th in five states: Massachusetts, Montana, North Carolina, South Carolina, and Texas — with nationwide availability to follow.

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: FDA, FDA Clearance

Tap Native

Get in-depth healthcare technology analysis and commentary delivered straight to your email weekly

Reader Interactions

Primary Sidebar

Subscribe to HIT Consultant

Latest insightful articles delivered straight to your inbox weekly.

Submit a Tip or Pitch

2026 Predictions & Trends

Healthcare 2026 Forecast: Executives on AI Survival, Financial Reckoning, and the End of Point Solutions

2026 Healthcare Executive Predictions: Why the AI “Pilot Era” Is Officially Over

Most-Read

NYC Health + Hospitals to Acquire Maimonides in $2.2B Safety Net Overhaul

NYC Health + Hospitals to Acquire Maimonides in $2.2B Safety Net Overhaul

KLAS Report: Why Hospitals Are Choosing Efficiency Over 'Agentic' AI Hype in 2025

KLAS Report: Why Hospitals Are Choosing Efficiency Over ‘Agentic’ AI Hype in 2025

Advanced Primary Care 2026: Top 6 Investments for Health Systems According to Harvard Medical School

Advanced Primary Care 2026: Top 6 Investments for Health Systems According to Harvard Medical School

AI Nutrition Labels: The Key to Provider Adoption and Patient Trust?

AI Nutrition Labels: The Key to Provider Adoption and Patient Trust?

Kristen Hartsell, VP of Clinical Services, RedSail Technologies

The Pharmacy Closures Crisis: How Independent Pharmacies Are Fixing Pharmacy Deserts

HHS Launches 'OneHHS' AI Strategy to Integrate AI Across CDC, CMS, and FDA for Efficiency and Public Trust

HHS Launches ‘OneHHS’ AI Strategy to Integrate AI Across CDC, CMS, and FDA for Efficiency and Public Trust

From Overwhelmed to Optimized: How AI Agents Address Staffing Challenges and Burnout in Healthcare

From Overwhelmed to Optimized: How AI Agents Address Staffing Challenges and Burnout in Healthcare

The VBC Paradox: Why Hospitals Are Doubling Down on Value-Based Care While Revenue at Risk Lags

The VBC Paradox: Why Hospitals Are Doubling Down on Value-Based Care While Revenue at Risk Lags

Tebra Secures $250M to Challenge Legacy EHRs with AI-Powered Automation

Tebra Secures $250M to Challenge Legacy EHRs with AI-Powered Automation

AstraZeneca Selects Salesforce Agentforce Life Sciences to Deploy AI-Powered Global Customer Engagement

AstraZeneca Selects Salesforce Agentforce Life Sciences to Deploy AI-Powered Global Customer Engagement

Secondary Sidebar

Footer

Company

  • About Us
  • Advertise with Us
  • Reprints and Permissions
  • Op-Ed Submission Guidelines
  • Contact
  • Subscribe

Editorial Coverage

  • Opinion
  • Health IT
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Population Health Management
    • Revenue Cycle Management
  • Digital Health
    • Artificial Intelligence
    • Blockchain Tech
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • Value-Based Care
    • Accountable Care
    • Medicare Advantage

Connect

Subscribe to HIT Consultant Media

Latest insightful articles delivered straight to your inbox weekly

Copyright © 2026. HIT Consultant Media. All Rights Reserved. Privacy Policy |