- Online OTC hearing aids use generic programming and cannot be truly custom programmed.
- Real ear measurements are required for evidence-based, personalized hearing aid programming.
- Class 2 prescriptive hearing aids fitted by an audiologist provide the most accurate results.
This year has brought significant changes to the field of audiology through the FDA’s introduction of over-the-counter (OTC) hearing aids. This legislation started five years ago in 2017, but the devices were officially released to be purchase starting in October 2022. The goal of this legislation was to provide cost-efficient, direct-to-consumer amplification devices to the public without the need to see a hearing healthcare specialist, audiologist.
This led to confusion, though—what is the difference between OTC hearing aids and hearing aids that you receive through a hearing healthcare professional? Can online hearing aids be custom-programmed?
Class 1 OTC vs Class 2 Prescriptive Hearing Aids
Hearing aids come in two class levels: Class 1 OTC hearing aids and Class 2 prescriptive medical hearing aids.
Level 1 devices are self-fit devices, meaning you do not have to have a prior hearing evaluation or consultation with a hearing healthcare provider in order to use these devices. These devices are intended to be used for individuals with perceived mild to moderate hearing loss and cannot assist with other auditory disorders, including tinnitus or hyperacusis. Class 1 devices are a one-size-fits-all model and allow for limited to no adjustments of the sound programming. These devices can be purchased at many big retail chain,s including Walmart, Best Buy, Costco, or online.
Level 2 prescriptive medical hearing aids require programming through an audiologist and are based on hearing acuity levels from a full diagnostic hearing evaluation. These devices can be used for all types and severities of hearing loss, are custom-fit to your listening preferences, and include separate computer programming chips to manage tinnitus and hyperacusis. These devices must be purchased through a healthcare professional’s office and often include repair, loss, and damage warranties.
Understanding Ways Hearing Aids Can Be Programmed
Depending on the type of device you have determines what type of programming can be activated by the internal computer chip.
Generic Programming (Class 1 OTC Devices)
The most basic level of programming is called generic programming. This programming is used in Class 1 OTC devices. Generic programming is based on average normative values from the population at large, not an individual’s specific hearing levels.
They have specifications to ensure the devices do not over-amplify any sounds, but essentially, they provide equal amounts of gain across all frequencies. Within generic programming, the computer chip cannot be adjusted, but it does allow for generic self-adjustment by the individual user. These self-adjustments include the ability to turn the overall volume up or down. This is the only modification that can be made to generic programming within Class 1 OTC devices.
Prescriptive Programming (Class 2 Devices)
Class 2 prescriptive devices allow for more personalized programming and can be either Manufacturer First Fit, In-situ First Fit, or customized programming.
Manufacturer First Fit is based on the specific hearing aid brand that you choose to purchase. Each manufacturer has their own proprietary fitting formula created using peer-reviewed research. Manufacturer First Fit takes into account your hearing thresholds at each frequency and only applies gain where hearing loss is present. It also separates soft, average, and loud sounds and treats them independently.
In-situ First Fit adds another level by completing a hearing evaluation through the hearing aids while they are in the listener’s ears. This allows the programming to be specified to both the individual’s hearing loss and the acoustics of the hearing aid dome or earmold and placement within the ear canal.
These first fits can be an excellent starting point, but real ear measurements are required for a precise individualized fit.
Importance of Real Ear Measurement
Real ear measurements follow current evidence-based best practices within the field of audiology and should be included at every hearing aid fitting appointment for Class 2 prescriptive devices.
Real ear measurements are completed by inserting a small flexible probe tube within the ear canal, typically 5 mm from the tympanic membrane. The hearing aids are then placed in the ear canals. The patient listens to recorded speech at soft, average, and loud levels while the probe tube microphone takes real-time output measurements.
These measurements are overlaid onto research-based prescriptive targets. Matching these curves demonstrates that the hearing aids are fit appropriately for the individual’s hearing loss and ear anatomy.
Why Ear Anatomy Matters in Programming
Imagine two people scheduled for hearing evaluations: a 7-year-old male and a 60-year-old female. Both have the exact same hearing loss degree and severity and chose the same hearing aids.
Their programming should not be identical because their ear anatomy is vastly different. Smaller ear canals require a different acoustic output than larger ones. Real ear measurements account for these differences, ensuring appropriate amplification without discomfort or distortion.
Limitations of Online Hearing Aid Programming
Real ear measurements require specialized equipment and training and cannot be completed via an online fitting. Class 1 OTC hearing aids cannot be fit with real ear measurements.
This can lead to sound issues, including over-amplification, discomfort, pain, or poor speech understanding. Background noise may be amplified equally, overpowering speech.
Can Online Hearing Aids Be Custom Programmed?
In short, can online hearing aids be custom-programmed? No—Class 1 OTC hearing aids cannot be custom programmed unless verified using real ear measurements.
With current legislation, many audiologists are not legally able to perform real ear measurements on Class 1 OTC devices. In order to receive evidence-based, customizable hearing aid programming based on your hearing loss and ear anatomy, Class 2 prescriptive hearing aids are currently required.
If you are looking for truly personalized care and long-term hearing success, working with an audiologist remains the gold standard for hearing aid fitting and programming.
