RoboHear™ Device: Advanced Haptic Technology That Allows the Deaf to Understand Speech

NCT03966144 | Withdrawn FDA Device

• 1 other identifier: 228355
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot study to test the feasibility of translating the English language into haptics (touch sensations)

Conditions

Hearing Impairment; Deafness

Outcome Measures

Primary Outcomes (1)

• Haptic Interpretation Test

  A computerized test to determine accuracy of interpretation of haptic stimuli in to sounds or words.

  at end of training session (1-3 hours), Day 1

Study Arms (1)

RoboHear Device

EXPERIMENTAL

Subjects will wear the Robo-Hear device and receive haptic stimuli. They will be tested on their ability to interpret these haptic sensations as sounds and words.

Device: RoboHear Device

Interventions

RoboHear Device DEVICE

Delivery of haptic sensations followed by testing to assess the ability to interpret stimuli as sounds and words

RoboHear Device

Eligibility Criteria

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

You may qualify if:

• Participants need to understand English.
• Participants must be able to sit at a computer for the training and evaluation session. The session may range from one hour to up to 4 hours in length (with breaks provided as needed).

You may not qualify if:

• Inability to understand English

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Hearing Loss; Deafness

Condition Hierarchy (Ancestors)

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

Study Officials

• John L Dornhoffer, MD, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will undergo computer based testing using the device to determine the number of haptic stimuli that are correctly interpreted as phenomes.

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 29, 2019
• Study Start: March 25, 2020
• Primary Completion: March 25, 2020
• Study Completion: March 25, 2020
• Last Updated: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)