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New CTA PSAP Quality Standard
Mead C. Killion, PhD, ScD(hon) & Gail Gudmundsen, AuDEtymotic Research, Inc.
ADA Audacity Conference San Diego 2016‐11‐12
1. What evidence do you have that PSAP aids that meet the new CTA PSAP performance standards will be satisfactory? In other words, can a CTA Seal‐of‐Approval assure that buyers will be satisfied? No
2. Do you think PSAPs will be good for audiologists and hearing instrument specialists? Sweetow: “That is the wrong question”
3. Do you expect satisfaction with a pair of PSAP or OTC hearing aids to approach that of hearing aids fitted by a professional? No
4. What is the return‐for‐credit rate for Etymotic’s “BEAN®” personal sound amplifiers? About the same as reported for the bottom half of professionals, who do not use best practices
(Starting with Some Interesting Questions)
BACKGROUND REMARKS
#1 There is a natural aging process that – if you live long enough ‐‐produces saggy skin and hearing loss. Neither is usually a medical problem which can be cured by a doctor.
#2 It is not good for someone with hearing loss to go without amplification, yet by one NU Kellogg Institute study, 55% of those who see a professional leave with nothing. Advice
and
#3 There are people who could benefit from conventional hearing aids but can’t afford them.a) 45 million in our country live below the poverty line;b) only 4% of the Hispanic population in Arizona with
hearing loss get hearing aids.
Zapala,Dhar etal. (2015‐IOM) DISEASE RISK MANAGEMENT
In addition, we are faced with double the number of people needing amplification, with no increase in the number of hearing professionals.
There will be plenty of people who can afford the best. We should be kind to those who can’t.
For all of those reasons,
Both PCAST and NAS (IOM) recently recommended that we permit over‐the‐counter hearing aids
The Warren‐Grassley Senate Bill just submitted further requires that FDA remover the “normal hearing” restriction on Personal Sound Amplifier Products (PSAPs) and would over ride the restrictions in all 50 states.
CTA PSAP Quality Standard (draft)
Update on the CTA PSAP Performance Standard
CTA PSAP Quality Standard (draft)Why Did the Consumer Technology Association form The
PSAP Quality Standard Committee?
To provide consumers with a “Good Houskeeping Seal of Approval”
for personal sound amplifiers that meet the requirements of the standard.
The task was challenging, because existing hearing aid standards describe how to measure hearing aids,
but are completely silent on what they should do.
The CTA PSAP Committee includes representatives from manufacturers, test labs, & other industry organizations.
Level 1: Performance Required (Results must be reported)
Example: Minimum Bandwidth
Level 2: Measurement Required (Results must be reported)
Example: Battery life
Level 3: Features and Options List (No requirements)Example: Multiband Compression
CTA PSAP Quality Standard (draft)
Three Levels of Performance Reporting
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Level 1 Criteria – Performance Measurement Limits:• Bandwidth: Standard > 5 kHz)(91-94% speech cues) & Wideband > 10 kHz(Music)
• Frequency response smoothness (no response peak >10dB)• Distortion limits for input & output• Maximum acoustic output: 115 dBA sound-field equivalent• Self-generated noise: 30 dBA maximum, referred to input(10 dB HL)
• Latency maximum: 15 ms (acoustic input to output)Level 2 Criterion – Measure & Report Value:
• Battery lifeLevel 3 Criteria – Features (Identified):
• Noise reduction• SNR enhancement (directionality)• Automatic gain and/or tone control• Feedback control/cancellation• Personalization• Ear canal open or closed
CTA PSAP Quality Standard (draft)
4.1 BANDWIDTH
Example
FAIL!
Example
FAIL!
Note: The maximum correction between 500 and 8000 Hz subtracts ‐5.4 dB at 2500 Hz. At that frequency, a 2‐cc coupler maximum SPL of 121 dB would fail the proposed standard.
Conversion Tables are provided that allow use of Standard 2cc coupler or Ear Simulator measurements
Ex: Proposed Maximum Allowable output is 115 dBA SPL referred to the sound field,
Table 4.5A allows correction of 2cc coupler values to Awt sound field SPLs
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A quick look at their data showed that none of these 27 devices would pass even the first three of the proposed CTA PSAP Standard requirements.
A year ago, the European Association of Hearing Aid Professionals provided data on 27 Personal Sound Amplifiers on the market in Europe
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APPLICATION EXAMPLES
I’m going to go quickly over them. If you want to download this ppt for more careful study, email customerservice @etymotic.com, put “ADA talk” in the subject line. You’ll receive the Dropbox url.
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Reasons for failing draft CTA standard
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Reasons for failing draft CTA standard
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Sound World Solutions CS50+
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Peak = 3 dBBW = 6.3 kHzMO = 113dB
In contrast to all those devices that fail
There are PSAPs (in the US) that do pass these tests
For one device, independent research has shown nearly as good speech intelligibility performance in quiet and in noise as digital hearing aids individually fitted to NAL‐NL2 (Walter Reed)
Another pass:
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NH
Peak = 3 dBBW = 16 kHz “Wideband”MO = 110dB
2 CC Coupler Responses
There has been a great deal of concern about the quality of PSAPs.
What about hearing aids?
Short A‐BA = open earB = Digital aid
In early fidelity‐rating experiments, we used a string quartet from the Chicago Symphony.
I even got to play onDvorak’s “American Quartet.”
We later found a simpler (and less expensive) method that gave similar ratings.
KEMAR THE PIANO PLAYER
A‐B: Boogie
A‐‐Open Ear B‐‐New Digital Aid “Q”
PSAP Example : High Fidelity BEAN® Personal Sound Amplifier with a 16 kHz BW
A‐B: Open Ear vs. BEAN PSAP
Draft standard appears to fail and pass devices appropriately
The standard will enable consumers to identify products with reasonable quality
Recommend: the FDA relax guidelines to allow these devices to be sold and
marketed realistically
CTA PSAP Quality Standard (draft)
Two Conclusions and a Recommendation
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Thank you!Not to mention that if you treat someone really well, you will have a customer for life. Gail has had patients track her down 15 years after she stopped practing.