# Over-The-Counter Hearing Aid Treatment For Adults With Cognitive Decline Due To Alzheimer's Disease And Related Dementias

> **NIH NIH R21** · NORTHWESTERN UNIVERSITY · 2023 · $443,758

## Abstract

Abstract
Alzheimer's disease and related dementias (ADRD) and their precursor, mild cognitive impairment (MCI), are a
major public health concern and a life-changing diagnosis for individuals and families. Most individuals with
ADRD or MCI also have hearing loss. When hearing and cognitive impairments co-occur, reduced ability to
deploy cognitive resources to inhibit distracting talkers, fill in missed words, or apply contextual knowledge to
improve understanding of a distorted signal means that listeners with ADRD may be less able to compensate for
untreated hearing loss than listeners without ADRD. Therefore, the combination of hearing loss and cognitive
impairment results in significantly greater functional limitations than either disability alone. OTC
were
advantages;
hearing aids
approved by the FDA after long advocacy by hearing loss support and eldercare groups and have potential
 namely, lower-cost hearing aids without the need for physician visits, referrals, and multiple
audiology appointments. However,
with
outcomes
communication
or
clinical
will
Aim
OTC aids have technology constraints that may limit their benefit for wearers
 impaired cognitive ability. Patients with different levels of impairment may also have different treatment
 related to t heir ability to adhere to treatment and how heir cognitive level impacts overall
ability. Therefore, there is a need for direct assessment of OTC t echnology for adults with ADRD
MCI and to determine the relative benefit of OTC aids over other interventions. Participants in this r andomized
trial will be recruited after diagnosis of either MCI or early ADRD along with mild hearing loss. Participants
be randomized to receive OTC aids or communication strategies tailored for adults with cognitive decline. In
 1, we will measure communication benefit for OTC hearing aids in older adults with ADRD or MCI. 
t
In
recognition of the key role of communication partners in the treatment model and in keeping with our focus on
real-life relevance, the primary outcome consists of subjective assessment of dyadic communication by the
listener's primary communication partner. Additional outcomes include hearing-related quality of life and
objective assessment of communication ability using conversation analysis. Each measure will be conducted at
baseline and after a 1-month trial. In Aim 2, we will characterize OTC hearing aid benefit across stages of
cognitive diagnosis (MCI compared to early ADRD). Primary analyses will employ a multivariable linear
regression model to compare the difference in primary outcome between arms. This proposed basic science
project will provide foundational evidence to guide treatment recommendations in older adults with MCI or early
ADRD, and will also establish feasibility data for future pragmatic clinical trials.

## Key facts

- **NIH application ID:** 10740008
- **Project number:** 1R21AG083928-01
- **Recipient organization:** NORTHWESTERN UNIVERSITY
- **Principal Investigator:** PAMELA E. SOUZA
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $443,758
- **Award type:** 1
- **Project period:** 2023-09-01 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10740008

## Citation

> US National Institutes of Health, RePORTER application 10740008, Over-The-Counter Hearing Aid Treatment For Adults With Cognitive Decline Due To Alzheimer's Disease And Related Dementias (1R21AG083928-01). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/10740008. Licensed CC0.

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