MEDICAL POLICY

POLICY
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DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

Stuttering Treatment Devices

Number 1.01.518

Effective Date July 24, 2013

Revision Date(s) 07/08/13; 07/10/12; 07/12/11; 06/08/10; 04/08/08; 03/13/07; 07/01/06

Replaces N/A

Policy

The use of stuttering treatment devices is considered investigational.

Related Policies

1.01.502

Augmentative and Alternative Communication Devices/Speech Generating Devices

8.03.505

Speech Therapy

Policy Guidelines

Stuttering devices may be used in conjunction with a structured fluency disorder rehabilitation program provided by a speech therapist.

Under some plans speech therapy may not be covered for stuttering in the absence of a medical or nervous system disorder. (See Related Policies)

Stuttering devices are not covered because they are considered investigational.

Coding

There are no specific CPT codes for stuttering devices

Description

Stuttering is a speech disorder that affects the fluency of speech. The disorder is characterized by disruptions in the production of speech sounds, also called "disfluency." This may present as repetitions or prolongations of speech sounds, syllables or words or by an individual’s inability to start a word. Stuttering usually begins in childhood during the time of language development between the ages of two to six. In some cases, stuttering lasts throughout life. About 1 percent or less of adults stutter. Males are three times more likely to stutter than females.

Background

At the present time there is no cure for stuttering. Standard treatment for the disorder involves speech therapy with a variety of therapeutic approaches. Many programs for persistent stuttering focus on relearning how to speak or behavior modification. Treatment often includes educating parents about restructuring the child’s environment to reduce episodes of stuttering. In some cases medications such as haloperidol and risperidone are used. Electronic devices for altered auditory feedback (AAF) have been proposed as a treatment method. The rationale for AAF lies in the observation that individuals who stutter tend to become more fluent when speaking in unison with others, a phenomenon called the choral effect. Delayed auditory feedback (DAF) delays the user’s voice to his or her ears. Frequency-shifted auditory feedback (FAF) alters the pitch of the user’s voice in his or her ears. Masking auditory feedback (MAF) synthesizes a sine wave that imitates vocal fold vibration and pulls the user out of silent blocks. The masking sound is triggered by a laryngeal microphone and played back to the user via an earpiece. The underlying mechanisms that enhance fluency under AAF have not been identified.

Regulatory Status

The U.S. Food and Drug Administration (FDA) categorizes stuttering or anti-stammering devices as Class I devices. As such, these devices are exempt from premarket notification procedures. (1) The FDA defines an anti-stammering device as one that electronically generates a noise when activated or when it senses the user’s speech that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user’s involuntary hesitative or repetitive speech. Trade names for anti-stammering devices include SpeechEasy® (Janus Development Group Inc., Greenville, NC), Fluency Master (National Medical Equipment Inc., New Hyde Park, NY), and Casa Futura’s Pocket Speech Lab and Basic Fluency System (Casa Futura Technologies, Boulder, CO).

SpeechEasy® devices utilize delayed auditory feedback (DAF) and frequency-shifted auditory feedback (FAF) to recreate and optimize the choral effect. The device is worn like a traditional hearing aid. When wearing a SpeechEasy® device the user’s words are digitally replayed in their ear with a very slight delay and frequency modification. This creates the illusion of speaking in unison with another person, which reportedly reduces stuttering in some individuals.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations.

Benefit Application

N/A

Rationale

This policy was originally created in 2007. Since that time the policy has been reviewed and updated using PubMed literature searches. The most recent literature review covered the period of June 2012 through June 2013. Following is a summary of the key literature.

The published literature on the clinical use and effectiveness of devices developed for the treatment of stuttering consists of a few reports, with extremely small numbers of patients in uncontrolled case series.

Kalinowski et al., in 2004, used a self-report format to assess the efficacy of an ear-level altered auditory feedback (AAF) device used by 105 participants. In each case, the device had been in use for an average of six months with minimal clinical intervention. Participants rated a significant improvement (P<0.001) after beginning to use the device. Based on the data, the authors concluded that the device helped to provide it’s users with functional, effective and efficient management of stuttering without the need for extensive clinical follow-up. (2,3)

In 2008, Stuart and colleagues examined objective and subjective measures of the effect of a self-contained ear-level device delivering altered auditory feedback (AAF) for those who stutter 12 months following initial fitting with and without the device. Nine individuals with developmental stuttering participated. In Experiment 1, the proportion of stuttering was examined during reading and monologue. A self-report inventory inquiring about behavior related to struggle, avoidance and expectancy associated with stuttering was examined in Experiment 2. In Experiment 3, naïve listeners rated the speech naturalness of speech produced by the participants during reading and monologue. The authors found that the proportions of stuttering events were significantly (p < 0.05) reduced at initial fitting and remained so 12 months post follow-up. After using the device for 12 months, self-reported perception of struggle, avoidance and expectancy were significantly (p < 0.05) reduced relative to pre-fitting. Naïve listeners rated the speech samples produced by those who stutter while wearing the device significantly more natural sounding than those produced without the device for both reading and monologue (p < 0.0001). They concluded that these findings support the notion that a device delivering AAF is a viable therapeutic alternative in the treatment of stuttering. However, study limitations included a very small sample size and a nonrandomized design.(4)

In 2009, Pollard and colleagues report on the effects of the SpeechEasy® when used under extraclinical conditions. Their primary purpose was to help establish Phase I level information regarding therapeutic utility of the SpeechEasy®. They also wanted to compare their results with previous findings. Eleven adults who stutter participated. A nonrandomized ABA group was utilized. Speech samples were collected every 2 weeks in extraclinical settings. Qualitative data were collected through weekly written logs and an exit questionnaire was completed. Group analyses revealed a statistically significant effect of the SpeechEasy® immediately post fitting but no treatment effect across 4 months’ time. Individual responses varied greatly with regard to stuttering frequency and subjective impressions. Relatively more stuttering reduction occurred during oral reading than during formulated speech. The authors concluded that Phase II trials were not indicated. (5)

In 2010, Lincoln and colleagues reported on 11 adults who participated in sessions with the study investigator(s) using an altered auditory feedback (AAF) device. Both speech and reading aloud skills were assessed while using the device. The results varied depending on the environmental conditions and device settings of the AAF during the testing sessions for each participant. The study was inconclusive as to the utility of the device for treatment of stuttering due to the inconsistancy of the data. No follow up data is available to document the long-term benefit after use of the device has ceased. (6)

Clinical Trial

A multicenter trial (NCT00001602) supported by the National Institute on Deafness and Other Communication Disorders of the National Institutes of Health (NIDCD/NIH) was completed in February 2005. Objectives of the trial included studying the pathognomony of stuttering, pursuing the delineation of subtypes in general but with particular reference to persistent and recovered stuttering. The study was designed to increase understanding of the genetic factors that may relate to stuttering, and ultimately to find out what causes stuttering. (7) According to the Stuttering Fact Sheet, NIDCD scientists have identified 3 genes -- one on chromosome 12 and two on chromosome 16—that are the source of stuttering in some study participants in Pakistan, England, and the United States. The 3 genes work together to breakdown and recycle cellular components that are tied to two serious metabolic disorders called mucolipidosis (ML) II and III. Researches are continiuing to study how this leads to specific problems with speech fluency. (8, 9).

Unger, et al. reported in 2012 on their study of the effects of altered auditory feedback (AAF) and one Inactive Condition (AAF parameters set to 0) on clinical attributes of stuttering during scripted and spontaneous speech. Two commercially available AAF devices were used to create the combined delayed auditory feedback (DAF) and frequency altered feedback (FAF) effects. The study participants were adults who stutter (n=30), aged 18-68 years (M=36.5; SD=15.2). Each subject produced four sets of speech samples that were analyzed to detect changes in descriptive features of stuttering (frequency, duration, speech/articulatory rate, core behaviors) and severity of stuttering. A statistically significant difference was found in the frequency of stuttered syllables (%SS) during both Active Device conditions (p=.000) for all speech samples. The most sizable reductions in %SS was in scripted speech. In the analysis of stuttering type, it was found that blocks were reduced significantly (Device A: p=.017; Device B: p=.049). The participants were divided into 2 groups based on the severity of stuttering. During the Inactive Condition those participantsin the moderate-severe group (p=.024) showed a statistically significant reduction in overall disfluencies. (10) According to the study authors this result indicates, that active AAF parameters alone may not be the sole cause of a fluency-enhancement when using a technical speech aid.

Summary

Based on a review of the published peer-reviewed scientific literature, there is insufficient evidence to conclude that stuttering devices are effective in the treatment of stuttering or dysfluency. The results of very small, uncontrolled case reports suggest that some individuals experience a decrease in stuttering while using AAF devices. However, well-designed prospective randomized controlled clinical trials are needed to establish the long-term utility of these devices and to define their role in the treatment of stuttering, when compared to standard or no treatment.

References

  1. U.S. Food and Drug Administration (FDA). Department of Health and Human Services (DHHS). Subchapter H—Medical Devices. Updated April 1, 2008. Accessed May 12, 2009. Available at URL address: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=874.5840. Last accessed June 3, 2013.
  2. Kalinowski J, Guntupalli VK, Stuart A, et al. Self-reported efficacy of an ear-level prosthetic device that delivers altered auditory feedback for the management of stuttering. Int J Rehabil Res; 2004; 27(2):167-70.
  3. Kalinowski J, Saltuklaroglu T. The road to efficient and effective stuttering management: information for physicians. Curr Med Res Opin. 2004; 20(4):509-15.
  4. Stuart A, Kalinowski J, Saltuklaroglu T, et al. Investigations of the impact of altered auditory feedback in-the-ear devices on the speech of people who stutter: one-year follow-up. Disabil Rehabil. 2006; 28(12):757-65.
  5. Pollard R, Ellis JB, Finan D et al. Effects of the SpeechEasy® on objective and perceived aspects of stuttering: a 6-month, phase I clinical trial in naturalistic environments. J Speech Lang Hear Res. 2009 Apr;52(2): 516-33.
  6. Lincoln M, Packman A, Onslow M, et al. An experimental investigation of the effect of AAF on the conversational speech of adults who stutter. J Speech Lang Hear Res. 2010 Mar 10. [Epub ahead of print]
  7. American Speech-Language-Hearing Association (ASHA). Recent Developments and Future Direction. Stuttering; ©1997-2013. Last accessed June 3, 2013.
  8. Stuttering Fact Sheet. National Institute on Deafness and Other Communication Disorders. NIDCD. NIH Pub. No. 10-4232. Updated March 2010. Available at URL address: http://www.nidcd.nih.gov/staticresources/health/voice/StutteringFactSheet.pdf. Last accessed June 3, 2013.
  9. American Speech-Language-Hearing Association (ASHA). ©1997-2013. In Search of Stuttering's Genetic Code Sep 18, 2012. Last accessed June 3, 2013.
  10. Unger JP, Glück CW, Cholewa J. Immediate effects of AAF devices on the characteristics of stuttering: a clinical analysis. J Fluency Disord. 2012 Jun;37(2):122-34.

Coding

Codes

Number

Description

CPT

   

ICD-9 Procedure

   

ICD-9 Diagnosis

307.0

Adult onset fluency disorder

 

315.35

Childhood onset fluency disorder

 

438.14

Late effects of cerebrovascular disease, speech and language deficits, fluency disorder

 

784.52

Fluency disorder in conditions classified elsewhere

ICD-10 Diagnosis
(effective 10/01/14)

   
 

F80.81

Childhood onset fluency disorder

 

F98.5

Adult fluency disorder

 

I69.023

Fluency disorder following nontraumatic subarachnoid hemorrhage

 

I69.123

…nontraumatic intracerebral hemorrhage

 

I69.223

…other nontraumatic intracranial hemorrhage

 

I69.323

…cerebral infarction

 

I69.823

…other cerebrovascular disease

 

I69.923

…unspecified cerebrovascular disease

 

R47.82

Fluency disorder in conditions classified elsewhere

HCPCS

E1399

Durable medical equipment, miscellaneous

Type of Service

Durable Medical Equipment

Outpatient

 

Place of Service

Home

 

Appendix

N/A

History

Date

Reason

3/14/06

Add to Durable Medical Equipment Section - New Policy adopted 3/14/06; held for notification—effective 07/01/06

03/13/07

Replace Policy - Policy updated with literature review; no change in policy statement.

04/08/08

Replace Policy - Policy update with literature search; no change to the policy statement. Reference added.

05/13/08

Code Update and Cross Reference Update - E1399 added; no other changes.

07/14/09

Replace Policy - Policy updated with literature review, no change to the policy statement. Reference added.

06/08/10

Replace Policy - Policy updated with literature search; no change to the policy statement. Reference added.

07/12/11

Replace Policy - Policy updated with literature search; no change to the policy statement.

07/20/12

Replace policy. Policy updated with literature search. ICD-9 codes added 315.35, 438.14, 784.52.The policy statement is unchanged.

07/24/13

Replace policy. Clarification statements about speech therapy added to policy guidelines. Regulatory information moved to new section under Description. Rationale section reformatted for usability. References renumbered to match rationale format. References older than 5-years that were not cited are removed. ICD-10 diagnosis codes added. Policy statement unchanged.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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