[Federal Register Volume 77, Number 72 (Friday, April 13, 2012)]
[Notices]
[Pages 22324-22326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8740]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Treatment of Tinnitus

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for scientific information submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from manufacturers of 
cochlear implants, sound masking devices, hearing aids, and 
transcranial magnetic stimulation medical devices. Scientific 
information is being solicited to inform our Comparative Effectiveness 
Review of Evaluation and Treatment of Tinnitus, which is currently 
being conducted by the Evidence-based Practice Centers for the AHRQ 
Effective Health Care Program. Access to published and unpublished 
pertinent scientific information on this device will improve the 
quality of this comparative effectiveness review. AHRQ is requesting 
this scientific information and conducting this comparative 
effectiveness review pursuant to Section 1013 of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003, Public 
Law 108-173.

DATES: Submission Deadline on or before May 14, 2012.

ADDRESSES:  Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submitscientific-information-packets/. Please select the 
study for which you are submitting information from the list of current 
studies and complete the form to upload your documents.
     Email submissions: [email protected] (please do not send zipped 
files--they are automatically deleted for security reasons).
     Print submissions: Robin Paynter, Oregon Health and Science 
University, Oregon Evidence-based Practice Center, 3181 SW Sam Jackson 
Park Road, Mail Code: BICC, Portland, OR 97239-3098.

FOR FURTHER INFORMATION CONTACT: Robin Paynter, Research Librarian, 
Telephone: 503-494-0147 or Email: [email protected].

SUPPLEMENTARY INFORMATION: In accordance with Section 1013 of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, 
Public Law 108-173, the Agency for Healthcare Research and Quality has 
commissioned the Effective Health Care (EHC) Program Evidence-based 
Practice Centers to complete a comparative effectiveness review of the 
evidence for evaluation and treatment of tinnitus.
    The EHC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by systematically requesting 
information (e.g., details of studies conducted) from medical device 
industry stakeholders through public information requests, including 
via the Federal Register and direct postal and/or online solicitations. 
We are looking for studies that report on treatment of tinnitus, 
including those that describe adverse events, as specified in the key 
questions detailed below. The entire research protocol, including the 
key questions, is also available online at: http://www.effectivehealthcare.AHRQ.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=811#4755.
    This notice is a request for industry stakeholders to submit the 
following:
     A current product label, if applicable (preferably an 
electronic PDF file).
     Information identifying published randomized controlled 
trials and observational studies relevant to the clinical outcomes. 
Please provide both a list of citations and reprints if possible.
     Information identifying unpublished randomized controlled 
trials and observational studies relevant to the clinical outcomes. If 
possible, please provide a summary that includes the following 
elements: study number, study period, design, methodology, indication 
and diagnosis, proper use instructions, inclusion and exclusion 
criteria, primary and secondary outcomes, baseline characteristics, 
number of patients screened/eligible/enrolled/lost to withdrawn/follow-
up/analyzed, and effectiveness/efficacy and safety results.
     Registered ClinicalTrials.gov studies. Please provide a 
list including the ClinicalTrials.gov identifier, condition, and 
intervention.
    Your contribution is very beneficial to this program. AHRQ is not 
requesting

[[Page 22325]]

and will not consider marketing material, health economics information, 
or information on other indications. This is a voluntary request for 
information, and all costs for complying with this request must be 
borne by the submitter. In addition to your scientific information 
please submit an index document outlining the relevant information in 
each file along with a statement regarding whether or not the 
submission comprises all of the complete information available.

    Please Note: The contents of all submissions, regardless of 
format, will be available to the public upon request unless 
prohibited by law.

    The draft of this review will be posted on AHRQ's EHC program Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted, please sign up for 
the email list at: http://effectivehealthcare.AHRQ.gov/index.cfm/join-the-email-list1/.

Key Question (KQ) 1 and PICOTS (Populations, Interventions, 
Comparators, Outcomes, Timing, and Setting)

    In patients with symptoms of tinnitus (e.g., ringing in the ears, 
whooshing sounds, etc.) what is the comparative effectiveness of 
methods used to identify patients for further evaluation or treatment?

Population(s)

    Adult patients presenting with symptoms of tinnitus (e.g., ringing 
in the ears, whooshing sounds, etc.)
    Note: ``Adults'' for all KQs will include individuals 18 years of 
age and older.

Interventions

    Direct observation or observation of sound with stethoscope; 
referral to a health professional with expertise on managing tinnitus 
(i.e., otolaryngologist, audiologist, neurologist, mental health 
professional; administration of scales/questionnaires to assess 
severity [e.g., Tinnitus Handicap Inventory, Tinnitus Reaction 
Questionnaire, Tinnitus Functional Index, Visual Analog Scale, and 
Tinnitus Severity Index, etc.])

Comparators

    Different clinical evaluation methods used to characterize a 
diagnosis and measure severity of subjective idiopathic tinnitus.

Outcomes

    Final outcome: No treatment; need for specialized treatment (e.g., 
audiology, otolaryngology, neurology, mental health care); extent of 
intervention.

Timing or followup

    No restrictions.

Setting

    Primary care; specialty care (audiology, otolaryngology, neurology, 
mental health care).

Key Question 2 and PICOTS

    In adults with subjective idiopathic (non-pulsatile) tinnitus, what 
is the comparative effectiveness (and/or potential harms) of medical/
surgical, sound treatment/technological, or psychological/behavioral 
intervention (including combinations of interventions)?

Population(s)

    Adult patients with a diagnosis of subjective idiopathic (non-
pulsatile) tinnitus (who are sufficiently bothered by tinnitus that 
they seek a treatment intervention)
    Note: For KQs 2 and 3, adults diagnosed with unilateral and/or 
pulsatile tinnitus need to be evaluated for other medical conditions 
(such as acoustic neuromas). Our review will include only those cases 
in which a medically serious underlying pathology as the source of the 
tinnitus has already been ruled out.

Interventions

    Any treatment/therapy used to reduce/help cope with tinnitus 
including but not limited to:

 Medical/Surgical
     Pharmacological treatments
     Tricyclic antidepressants (e.g., amitriptyline, 
nortriptyline, and trimipramine)
     Selective serotonin-reuptake inhibitors: Fluoxetine and 
paroxetine
     Other: Trazodone; anxiolytics (e.g., alprazolam); 
vasodilators and vasoactive substances (e.g., prostaglandin El); 
intravenous lidocaine; gabapentin; Botox (botulinum toxin type A); and 
pramipexole)

 Laser treatments
 TMJ treatment: Dental orthotics and self-care; surgery
 Transcranial magnetic stimulation
 Complementary and alternative medicine therapies: G. biloba 
extracts; acupuncture; hyperbaric oxygen therapy; and diet, lifestyle, 
and sleep modifications (caffeine avoidance, exercise)

 Sound Treatments/Technologies
     Hearing aids
     Cochlear implants
     Sound generators/maskers (both wearable and stationary)
     Neuromonics
     Tinnitus Retraining Therapy
 Psychological/Behavioral
     Cognitive behavioral therapy
     Biofeedback
     Education
     Relaxation therapies
     Progressive Tinnitus Management

 Combination therapies
     Any combination of tinnitus interventions (e.g., 
pharmacological treatment with cognitive behavioral therapy)

Comparators

    Placebo; no treatment; wait list; treatment as usual; other 
intervention/treatment.

Outcomes

 Final outcomes
    1. Sleep disturbance
    2. Discomfort
    3. Anxiety
    4. Depression
    5. Self-reported loudness
    6. Quality of life

 Adverse effects
    1. Worsening of tinnitus
    2. Sedation
    3. Surgical complications

Timing or followup

    No restrictions.

Setting

    Primary care; specialty care (audiology, otolaryngology, neurology, 
and mental health care).

Key Question 3 and PICOTS

    For adults with subjective idiopathic tinnitus, what prognostic 
factors, patient characteristics, and/or symptom characteristics affect 
final treatment outcomes?

Population(s)

    Adults with a diagnosis of subjective idiopathic tinnitus 
(sufficiently bothered by tinnitus that they are seeking a treatment 
intervention).

Interventions

    Any treatment/therapy used to reduce/help cope with tinnitus 
including but not limited to those described in KQ 2.

Comparators

 Prognostic factors: Length of time to treatment after onset, 
audiological factors (degree and type of hearing loss, hyperacusis, 
loudness tolerance, masking criteria, etc.), head injury, anxiety, 
mental health disorders, and duration of tinnitus
 Patient characteristics: Age, gender, race, medical or mental 
health

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comorbidities, socioeconomic factors, noise exposure (environmental, 
recreational and work-related [including active and past military duty, 
and occupational hazards), involvement in litigation, third-party 
coverage
 Symptom characteristics: Origin/presumed etiology of tinnitus, 
ototoxicity, tinnitus duration since onset, subcategory of tinnitus, 
severity of tinnitus

Outcomes

 Final outcomes
    1. Time until improvement
    2. Sleep disturbance
    3. Discomfort
    4. Anxiety
    5. Depression
    6. Self-reported loudness
    7. Quality of life
    8. Return to ``normal'' work
 Adverse effects
    1. Worsening of tinnitus
    2. Sedation
    3. Surgical complications

Timing or Followup

    No restrictions.

Setting

    Primary care; specialty care (audiology, otolaryngology, neurology, 
mental health).

    Dated: April 4, 2012
Carolyn M. Clancy,
Director, AHRQ.
[FR Doc. 2012-8740 Filed 4-12-12; 8:45 am]
BILLING CODE 4160-90-M