Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding

NCT00582946 | Completed Phase 1 Results DMC

• 2 other identifiers: R43DC008499-01R44DC008499
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Our goal is to design and build a new hearing aid system, which mitigates the most common complaints that hearing aid users have. These include hearing in multi-talker situations, poor sound quality, unwanted whistling resulting from feedback, and a dislike of the sound of their own voice. Current efforts, with limited success, use signal processing methods rather than restoring more closely the normal auditory function. We plan to achieve our goal by reducing to practice three key enabling concepts. The first is to replace the current acoustic transducer with a non-acoustic mechanical output transducer that directly actuates the tympanic membrane (TM). This transducer, called the EarLens, floats on the tympanic membrane in a manner similar to the way a contract lens floats on the eye. The second is to increase the output bandwidth of the hearing aid. The third key concept is to place a wide-bandwidth microphone in the ear canal to capture the pinna diffraction cues similarly to the way the normal ear functions. Our central hypothesis is that a hearing aid that delivers amplified wide-bandwidth mechanical stimuli, directionally dependent cues, in an open canal configuration will perform better than conventional hearing aids when there are competing talkers in the background. First phase includes verification the capability of the system to deliver sufficient maximum equivalent pressure output (MEPO) to treat the degree of hearing loss in the target fitting range.

Conditions

Hearing Impairment

Keywords

Hearing Loss, Eardrum, Transducer, Hearing in Noise

Outcome Measures

Primary Outcomes (1)

• Maximum Effective Sound Pressure Level (MEPO)

  A primary outcome measure of interest is an estimate of the insitu maximum equivalent pressure output (MEPO) of the EarLens system, which represents the sound pressure level that would have to be applied at the eardrum (or tympanic membrane) to produce the same degree of tympanic membrane (TM) vibration that the EarLens system produces with the coil current set to its maximum value, and given the anatomical constraints on the coupling between the coil and magnet for a given subject. The target fitting range included hearing loss up to 60 decibels (dB) Hearing Level (HL). In order for the device to be an effective hearing aid for this target population, the maximum output of the device needs to be able to provide output and gain to treat this maximum hearing loss.

  1 month

Study Arms (1)

Magnetic Contact Hearing Aid

EXPERIMENTAL

Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.

Device: Hearing Aid

Interventions

Hearing Aid DEVICE

Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss.

Magnetic Contact Hearing Aid

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hearing loss less than 60 dB at any frequency, no conductive hearing loss

You may not qualify if:

• Collapsed ear canal, damaged or repaired middle ear, too much sensory hearing loss

Sponsors & Collaborators

• EarLens Corporation: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Ear Lens Corporation

Redwood City, California, 94063, United States

Location

Related Publications (1)

• Perkins R, Fay JP, Rucker P, Rosen M, Olson L, Puria S. The EarLens system: new sound transduction methods. Hear Res. 2010 May;263(1-2):104-13. doi: 10.1016/j.heares.2010.01.012. Epub 2010 Jan 29.

  PMID: 20116419 RESULT

Related Links

• Electromagnetic EarLens system published in Hearing Research

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Results Point of Contact

• Title: Sunil Puria
• Organization: EarLens Corporation

spuria@earlenscorp.com

650-366-9000

Study Officials

• Sunil Puria

  Ear Lens Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical, For Sunil Puria, Chief Scientist (no longer with company)

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: May 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 4, 2016
• Results First Posted: October 3, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)