Remote Microphone Candidacy Study

NCT03897634 | Completed Results FDA Device

• 1 other identifier: SP0053453
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Despite improvements in digital hearing aid technology, many hearing aid users continue to report difficulty understanding speech in challenging listening environments. Remote microphones have been shown to provide benefit in the most common of these challenging listening environments: distant speakers, background noise, and reverberation. Despite demonstrated benefit, there is a low rate of remote microphone use among adult hearing aid users. One reason for low uptake may be an uncertainty among hearing healthcare providers and potential users regarding expected clinically relevant benefit. This clinical trial will attempt the following:

1. 1.To describe the range of remote microphone benefit among adults with mild-to-moderate sensorineural hearing loss
2. 2.To determine specific individual factors beyond the audiogram that are associated with greater benefit from remote microphones

Conditions

Hearing Loss, Sensorineural

Keywords

Assistive Listening Device (ALD); Hearing in Noise

Outcome Measures

Primary Outcomes (1)

• Change in Abbreviated Profile of Hearing Aid Benefit (APHAB)

  Self assessment, disability based inventory that is used to document outcomes of hearing aid fittings. The APHAB uses a percentile scale (Percent of Problems). This measure has 4 subscales: Ease of communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV). A lower score indicates a better outcome. We will look at both the global change (defined as EC, RV, and BN scores improving by at least 5 points each) and individual subscales (For EC, RV, or BN a change in 22 points is considered significant and for AV a change of 31 points is needed to be considered significant).

  Change from baseline to final appointment will be assessed. Participants will take a baseline at the start of the trial and then complete post-intervention at the end of the 30-day trial.

Secondary Outcomes (2)

• Change in Speech, Spatial, and Qualities of Hearing (SSQ)

  Change from baseline to final appointment will be assessed. Participants will take a baseline at the start of the trial and then complete post-intervention at the end of the 30-day trial.

• % of Words Repeated Correctly in a Sentence Recognition Task With Variable Levels of Background Noise

  End of trial: Objective speech intel was collected in one session at the end of the 30 day trial with the remote microphone. Order of conditions (Hearing aid only and Hearing Aid+ Remote Mic) was randomized.

Study Arms (1)

Experiences Hearing Aid user

EXPERIMENTAL

Single arm study, all participants in this arm. Participants will be experienced hearing aid users.

Device: Remote Microphone

Interventions

Remote Microphone DEVICE

Experienced hearing aid users will be trained on and use a remote microphone for 30 days. Pre- and Post- measures will be taken to determine benefit. Participant characteristics will also be assessed (such as self-efficacy) to explore personality factors that may contribute to benefit from devices.

Also known as: Roger Select

Experiences Hearing Aid user

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18-85 years
• Speak English as their primary language
• Normal or corrected to normal vision
• Sensorineural hearing loss with pure-tone thresholds 20-85 dB HL at octave frequencies between 500 and 3000 Hz
• Current hearing aid wearer with at least 3 months of experience

You may not qualify if:

• Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator places the participant at unacceptable risk if he or she were to participate in the study
• Participants who do not pass a cognitive screening test (e.g., MoCA)
• Significant history of otologic or neurologic disorders
• Conductive hearing loss pathology or fluctuating hearing loss

Sponsors & Collaborators

• Northwestern University: lead
• Phonak AG, Switzerland: collaborator

Study Sites (1)

Northwestern University

Evanston, Illinois, 60208, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kendra Marks
• Organization: Northwestern University

kendra.marks@northwestern.edu

847-467-0897

Study Officials

• Pamela Souza, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Within-subject design: Baseline assessments compared to post-trial results.

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: April 1, 2019
• Study Start: August 30, 2019
• Primary Completion: March 15, 2020
• Study Completion: April 15, 2020
• Last Updated: June 10, 2021
• Results First Posted: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)