Closed-loop Rehabilitation for Hyperactive Hearing

Harnessing Endogenous Brain Plasticity Systems for the Recalibration of Pathological Auditory Percepts

There are no widely available treatments for the underserved populations with tinnitus, hyperacusis, and hearing-in-noise deficits. Left unmanaged, these disorders can lead to a wide range of negative psychosocial and emotional sequelae including anxiety, depression, fear, and social isolation. The proposed research will investigate a novel closed-loop sound therapy designed to address the mutual basis of these disorders.

Study Overview

• Status: Withdrawn
• Conditions: Hyperacusis; Tinnitus
• Intervention / Treatment: Behavioral: Sound Therapy 1; Behavioral: Sound therapy 2

Detailed Description

Upwards of 700 million people are projected to require rehabilitative services for hearing disorders by the year 2050 (Chadha, Kamenov, & Cieza, 2021). Many will suffer not from what is inaudible but from the presence of insuppressible sound. Individuals may be overwhelmed by phantom sounds that do not exist external to the auditory system (tinnitus) (Henry, Dennis, & Schechter, 2005). Moderate intensity sounds may have malformed percepts that induce loudness, annoyance, fear, or pain (hyperacusis) (Tyler et al., 2014). Sounds may also appear engulfed by other noises in the environment (Plack, Barker, & Prendergast, 2014). These hearing disorders are co-morbid with one another with roughly 80% of tinnitus patients reporting reduced sound level tolerance (Anari et al., 1999). Hyperacusis, tinnitus, and hearing-in-noise deficits are common chronic disorders within middle-aged/older adults but can also affect younger ages, with noise exposure history and traumatic brain injuries as key predictors. The outlined hearing disorders are complicated and heterogeneous making them challenging to treat. Consequently, despite a clear demand for rehabilitative services, there are no widely accepted nor effective treatments available (Baguley and Hoare, 2018). The result of this is typified in tinnitus patients, of whom 84.8% have never attempted any form of remedy (Bhatt, Lin, & Bhattacharyya, 2016).

We propose a therapeutic strategy that is founded upon the most beneficial aspects of previously conducted randomized controlled trials (RCTs). Namely, the therapy will employ a closed-loop system. The research capitalizes on promising findings from current studies in animal models, seeking to take advantage of the neuroscience principles thought to operationalize paired plasticity. The therapy is entirely non-invasive, posing minimal risk to the patient, and is translatable to widely available hardware. The research will use a "gold-standard" randomized, double-blinded, placebo-controlled clinical trial to objectively evaluate its worth.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Normal audiometric thresholds
• Subjects with tinnitus will have self-reported chronic tinnitus that has persisted for the duration of at least 6 months
• Subjects with hyperacusis will have a clinical diagnosis of hyperacusis and/or self-reported sound tolerance complaints that have persisted for the duration of at least 6 months

Exclusion Criteria:

• Conductive hearing loss (as assessed by audiologist)
• Active otologic disease (as assessed by audiologist)
• Significant cognitive decline (Montreal Cognitive Assessment score > 25)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sound Therapy Group 1; Closed-loop sound therapy. Weekly sessions over 6 weeks.	Behavioral: Sound Therapy 1; Closed-loop sound therapy.
Placebo Comparator: Sound Therapy Group 2; Placebo sound therapy. Weekly sessions over 6 weeks.	Behavioral: Sound therapy 2; Placebo sound therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Score on the Tinnitus Reaction Questionnaire		Pre-test / Post-test (6 weeks) / Follow-up (14 weeks)
Reduction in Loudness Discomfort Levels	The intensity of pulsated pure tones of 55 ms reported to be uncomfortably loud (test commonly employed in hearing aid fitting).	Pre-test / Post-test (6 weeks) / Follow-up (14 weeks)
Change in Speech Recognition in Noise Performance Accuracy	Keyword recognition accuracy for sentences in noise will be assessed with a clinical test, the QuickSiN. Signal to noise ratios vary from 25 to 0 dB in 5 dB steps.	Pre-test / Post-test (6 weeks) / Follow-up (14 weeks)

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary
• Investigators: Principal Investigator: Daniel B Polley, Ph.D., Massachusetts Eye and Ear Infirmary

Study record dates

Study Major Dates

• Study Start (Estimated): September 21, 2022
• Primary Completion (Estimated): September 21, 2023
• Study Completion (Estimated): September 21, 2023

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Tinnitus; Hyperacusis
• Other Study ID Numbers: pending_102121

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No