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Efficacy and Effectiveness of Direct to Consumer Devices and Interventions

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1.  Which of the following is currently unregulated by the Food and Drug Administration:
  1. Personal Sound Amplification Products
  2. Bone anchored implants
  3. Hearing aids fitted by audiologist or hearing aid dispenser
  4. Cochlear Implants
2.  Much of the Personal Sounds Amplification Product evaluation literature has focused around:
  1. Clinical Trials
  2. Electroacoustic Analysis
  3. Objective speech testing
  4. Effectiveness trials
3.  In comparing PSAPs to a Hearing Aid on speech in noise measures, which device performed best by a slim margin:
  1. SoundWorld Solutions
  2. SoundHawk
  3. Hearing aid
  4. Etymotic Bean
4.  Which of the following is a limitation to comparison of PSAPs and a Hearing Aid efficacy study:
  1. controlled environment
  2. non-real world fitting styles (i.e. user fitting is unaccounted for)
  3. both A and B
  4. none of the above
5.  Which of the following best describes an "effectiveness" study:
  1. Testing the electroacoustic capabilities of devices in a testbox
  2. Comparing how well devices improve participant's speech recognition in background noise in a soundproof booth
  3. Comparing how well devices improve participant's speech recognition without background noise in a soundproof booth
  4. A 6-month trial of user-fit versus audiologist-fit devices
6.  The Over-the-Counter hearing aids described in the legislative bill would serve persons with which type of hearing loss?
  1. mild to moderate
  2. severe
  3. profound
  4. mild only
7.  In the Baltimore HEARS pilot, what percentage of participants recommended the program:
  1. 20%
  2. 50%
  3. 80 %
  4. 100%
8.  Which of the following did the Baltimore HEARS program utilize to help reinforce and support lessons learned during sessions:
  1. goal setting
  2. communication partners
  3. easy to read materials
  4. all of the above
9.  The BALTIMORE HEARS intervention is delivered by a team consisting of an audiologist and a _______?
  1. social worker
  2. community health worker
  3. speech language pathologist
  4. physician
10.  Outcomes used in the Baltimore HEARS pilot include:
  1. Hearing Handicap Inventory (Perceived impact of hearing loss)
  2. UCLA Loneliness Scale (loneliness)
  3. SF-36 (Quality of Life)
  4. All of the above

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