๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-12

OTC Hearing Aid and MCI (NCT06112860)

Over-the-counter Hearing Aids and Mild Cognitive Impairment

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Northwestern University

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The goal of this study is to better understand if, in patients with mild to moderate hearing loss who are also experiencing mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD), Over-the-Counter (OTC) hearing aids: 1. improve communication 2. Whether the magnitude of benefit depends on the patient's level of cognitive disability, 3. Whether alternative remediation (such as targeted communication strategies) offer similar benefits. Participants and a communication partner will be randomized into an OTC first or Communication Strategies first arm, where participants will receive communication strategy information customized for those with cognitive impairment.

Who can join: Review the eligibility criteria below.

Location: Northwestern University HA Lab โ€” Evanston, Illinois

Age range: 60 Years to 90 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (3 Sites)

  • Northwestern University HA Lab โ€” Evanston, Illinois
  • La Crosse Mayo Clinic โ€” La Crosse, Wisconsin
  • UW Madison โ€” Madison, Wisconsin

๐Ÿ“ž Contact the Study Coordinator

Phone: (847) 467-0897

Email: kendra.marks@northwestern.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Hearing Loss clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—