Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00787189
Recruitment Status : Completed
First Posted : November 7, 2008
Results First Posted : July 11, 2011
Last Update Posted : April 24, 2014
Information provided by (Responsible Party):
Erchonia Corporation

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Sensorineural Hearing Loss
Interventions: Device: The Hearing Laser
Device: Placebo Laser

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
40 subjects (80 ears) were recruited across two hearing aid and evaluation test sites from May, 2007 to October, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
4 subjects (8 ears) were disqualified because the word recognition score recorded for study qualification purposes exceeded the upper inclusive limit of 86% words correct. 4 subjects (8 ears) were disqualified because the subject’s primary spoken language was not English, which was also a study exclusion criteria.

Reporting Groups
Active Active laser device
Control Placebo laser device

Participant Flow:   Overall Study
    Active   Control
STARTED   32   32 
COMPLETED   30 [1]   30 [1] 
Lost to Follow-up                2                2 
[1] To study end point.

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Active Active laser device
Control Placebo laser device
Total Total of all reporting groups

Baseline Measures
   Active   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   32   64 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   6   0   6 
>=65 years   26   32   58 
[Units: Years]
Mean (Standard Deviation)
 78.94  (5.92)   76.00  (9.86)   77.47  (8.265) 
[Units: Participants]
Female   10   18   28 
Male   22   14   36 

  Outcome Measures

1.  Primary:   Participants Whose Change in Percent Correct Word Recognition Scores From Baseline to One Week After Study Treatment Equalled or Exceeded the Minimum Change in a Reference Chart.   [ Time Frame: baseline and one week ]

2.  Secondary:   Tinnitus, Hearing-related Quality of Life   [ Time Frame: up to 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Elvira Walls, Clinical Consultant
Organization: Regulatory Insight, Inc.
phone: 615-712-9743

Responsible Party: Erchonia Corporation Identifier: NCT00787189     History of Changes
Other Study ID Numbers: EHL-001
First Submitted: November 6, 2008
First Posted: November 7, 2008
Results First Submitted: June 23, 2009
Results First Posted: July 11, 2011
Last Update Posted: April 24, 2014