Validation of a Smartphone-Based Hearing-in-Noise Test (HearMe)

NCT03429777 | Withdrawn FDA Device

• 1 other identifier: 201712793
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this project is to validate a quick, easy-to-use and administer smartphone hearing-in-noise test. The Hearing-in-Noise Test (HINT) measures an individual's ability to hear speech in quiet and in noise. HINTs are traditionally done testing both ears together as binaural hearing ability is key in noisy settings and everyday, functional hearing. The app (called HearMe) can potentially be used to easily and quickly collect hearing-in-noise and speech-in-noise measurements. The smartphone app developed is a hearing-in-noise test that presents the subject with a series of stimuli consisting of a spoken three-digit sequence presented at a varying hearing-to-noise ratio. For each stimulus presentation, the user tap the three-digit sequence. The duration of the app is less than 3 minutes. For this project the investigators will test at least 50 subjects with hearing loss and 50 control subjects between the ages of 18-80. The subjects will be invited to take the app. The approach for this pilot study is to characterize hearing-in-noise thresholds (also referred to as a speech-reception threshold) as measured by the app in both subject groups, and relate it to the phenotype of each group as a preliminary evaluation of the app as well as a preliminary validation against their routinely collected measurements of hearing function (pure-tone audiometry thresholds). The study will assess the validity of the test construct in measuring hearing-in-noise thresholds, and serve as a foundation for further iterative designs of the app and future validation and characterization studies. This study seeks to validate a developed smartphone HINT on an initial cohort of patients and controls. It is anticipated that patients with hearing loss will display higher signal-to-noise ratio thresholds (as measured by the iPhone app) compared to controls.

Conditions

Hearing Loss; Hearing Disorders; Hearing Abnormality; Hearing Disability; Tinnitus

Keywords

Smartphone; Medical application; Hearing-in-noise test; Digits-in-noise test; Speech reception threshold; Hearing Loss; Hearing Disorders; Hearing Abnormalities; Tinnitus; Hearing aids; Cochlear implants

Outcome Measures

Primary Outcomes (1)

• Standardized Hearing Tests (change in hearing)

  Pure-tone audiometry threshold (threshold of hearing relative to frequency)

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Quick Hearing Check Questionnaire (change in hearing)

  Through study completion, an average of 1 year

• Standardized Hearing Loss Questionnaire (change in hearing)

  Through study completion, an average of 1 year

• Tinnitus Questionnaires (change in hearing)

  Through study completion, an average of 1 year

Study Arms (2)

Hearing Loss Group

EXPERIMENTAL

The investigators will characterize hearing-in-noise thresholds (also referred to as a speech-reception threshold) as measured by the HearMe app in patients with hearing loss.

Device: HearMe Smartphone Application

Control Group

ACTIVE COMPARATOR

The investigators will characterize hearing-in-noise thresholds (also referred to as a speech-reception threshold) as measured by the HearMe app in control subjects without any prior or current hearing loss.

Device: HearMe Smartphone Application

Interventions

HearMe Smartphone Application DEVICE

The HearMe smartphone application is a digits-in-noise test that can be used to digitally quantify speech reception thresholds.

Also known as: HearMe, HearMe IA

Control Group; Hearing Loss Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age-matched (18-100)
• Healthy normal controls with no known hearing loss
• Patients with clinically assessed hearing loss

You may not qualify if:

• Complete hearing loss/deafness
• Cognitive decline or dysfunction, dementia

Sponsors & Collaborators

• University of Iowa: lead

Related Publications (10)

• Ciorba A, Bianchini C, Pelucchi S, Pastore A. The impact of hearing loss on the quality of life of elderly adults. Clin Interv Aging. 2012;7:159-63. doi: 10.2147/CIA.S26059. Epub 2012 Jun 15.

  PMID: 22791988 BACKGROUND

• Culling JF, Zhao F, Stephens D. The viability of speech-in-noise audiometric screening using domestic audio equipment. Int J Audiol. 2005 Dec;44(12):691-700. doi: 10.1080/14992020500267017.

  PMID: 16450920 BACKGROUND

• Dalton DS, Cruickshanks KJ, Klein BE, Klein R, Wiley TL, Nondahl DM. The impact of hearing loss on quality of life in older adults. Gerontologist. 2003 Oct;43(5):661-8. doi: 10.1093/geront/43.5.661.

  PMID: 14570962 BACKGROUND

• Davis A, Smith P, Ferguson M, Stephens D, Gianopoulos I. Acceptability, benefit and costs of early screening for hearing disability: a study of potential screening tests and models. Health Technol Assess. 2007 Oct;11(42):1-294. doi: 10.3310/hta11420.

  PMID: 17927921 BACKGROUND

• DePaolis RA, Janota CP, Frank T. Frequency importance functions for words, sentences, and continuous discourse. J Speech Hear Res. 1996 Aug;39(4):714-23. doi: 10.1044/jshr.3904.714.

  PMID: 8844552 BACKGROUND

• Grant KW, Walden TC. Understanding excessive SNR loss in hearing-impaired listeners. J Am Acad Audiol. 2013 Apr;24(4):258-73; quiz 337-8. doi: 10.3766/jaaa.24.4.3.

  PMID: 23636208 BACKGROUND

• Houtgast T, Festen JM. On the auditory and cognitive functions that may explain an individual's elevation of the speech reception threshold in noise. Int J Audiol. 2008 Jun;47(6):287-95. doi: 10.1080/14992020802127109.

  PMID: 18569101 BACKGROUND

• Jansen S, Luts H, Dejonckere P, van Wieringen A, Wouters J. Exploring the sensitivity of speech-in-noise tests for noise-induced hearing loss. Int J Audiol. 2014 Mar;53(3):199-205. doi: 10.3109/14992027.2013.849361. Epub 2013 Nov 18.

  PMID: 24237040 BACKGROUND

• Killion MC, Niquette PA, Gudmundsen GI, Revit LJ, Banerjee S. Development of a quick speech-in-noise test for measuring signal-to-noise ratio loss in normal-hearing and hearing-impaired listeners. J Acoust Soc Am. 2004 Oct;116(4 Pt 1):2395-405. doi: 10.1121/1.1784440.

  PMID: 15532670 BACKGROUND

• Potgieter JM, Swanepoel de W, Myburgh HC, Hopper TC, Smits C. Development and validation of a smartphone-based digits-in-noise hearing test in South African English. Int J Audiol. 2015 Jul;55(7):405-11. doi: 10.3109/14992027.2016.1172269. Epub 2016 Apr 28.

  PMID: 27121117 BACKGROUND

Related Links

• American National Standard, Methods for Calculation of the Speech Intelligibility Index.

MeSH Terms

Conditions

Hearing Loss; Hearing Disorders; Tinnitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Zarei

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Model Details: For this study the investigators will test at least 50 subjects with some form or hearing loss and 50 control subjects between the ages of 18-80. The subjects will be invited to take the app. The approach for this study is to characterize hearing-in-noise thresholds (also referred to as a speech-reception threshold) as measured by the app in both subject groups.

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: February 12, 2018
• Study Start: August 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share