Hearing aids amplify the audio signals entering the ears, thus improving the audibility of the sound. Smartphone-based hearing aids can allow the users to control the volume and frequency-gain response as per their comfort level, thereby making them a viable alternative to conventional hearing aids. In Reference [ ], the feasibility of smartphone applications based hearing aids was studied on a group of people aged between 50 and 90 years with mild-to-moderately severe hearing loss, who had been using hearing aids for less than 3 months.
The participants used a conventional hearing aid and two smartphone apps, EARs and microphone, each for 2—3 weeks.
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While using the smartphone apps they attached an inline microphone to the shirt and in-ear headphones to the phone. From the electroacoustic measurements and speech-in-noise test, the authors observed similar performance among all three devices. However, the authors attributed the differences in the placement of microphones in the hearing aid compared to the smartphone apps for similar speech-in-noise performance.
In addition, the participants overall showed greater satisfaction with smartphone applications compared to the hearing aids. A smartphone-based hearing assistive system was presented in Reference [ ] to assist people with mild-to-moderate hearing loss.
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The PCM signals are then transmitted over the Bluetooth medium to a receiver, which converts the digital signal back to the analog domain and sends the analog signal to the ear through headphones. The authors reported achieving an average improvement in speech intelligibility by 0. As smartphone-based health monitoring systems and applications are increasing rapidly and becoming more pervasive in society, there is a growing concern about the safety issues and associated potential dangers [ , ]. Furthermore, in January , a team of researchers [ ] conducted a search for suitable apps in the iTunes App Store and Google Play that can assist people to deal with anxiety disorders and selected 52 apps for study.
They found that Only two out of the 52 anxiety apps were found to be thoroughly tested by the psychiatrists [ ]. Therefore, cautious use of many of these applications was advised in References [ , ] due to their diagnostic inaccuracies and unreliability. Some of them are reported to be unsafe to use [ , , ] and even may cause life-threating consequences [ ]. Hence, adoption and enforcement of some regulatory policies were recommended by the experts [ , ] to ensure accountability, data-privacy, information security and patient welfare in terms of safety and diagnostic effectiveness.
These experts urged the FDA to draw a clear demarcation line between the medical apps and the fitness or wellness app, as well as between diagnosing apps and monitoring apps.
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They recommended for defining the risk-level threshold of regulatory significance for medical apps. They also suggested defining the boundaries of FDA regulations for apps serving as device accessories and making a guideline to deal with the modular applications. In February , the FDA released the latest version of the guidelines defining the categories of smartphone-based healthcare applications that must require regulatory oversight [ ]. Regulatory oversight will also be applied to those applications that can be used as an accessory to the FDA-approved medical devices such as a smartphone-based ECG monitor.
However, if a device demonstrates substantially similar performance to an already approved and legally marketed device predicate device , it may enjoy an exemption from new clinical trials upon proper evidence that shows the device has same intended use and technological characteristics as the predicate device [ ]. In the case when the new device has different technological characteristics in terms of device safety and effectiveness—first, it must not raise any new concerns, and second, it must meet the minimum standards of the predicate device [ ].
Nevertheless, there remain serious concerns about safety assurances in the process of device approval based on predicate devices. Therefore, both the Institute of Medicine [ ] and the U. Congress [ ] understandably urged to curtail this approach of device approval. So far, the FDA has approved several healthcare applications developed for the mobile platform [ ].
This app allows a healthcare professional to view, assess and securely share images with patients, peers or partner institutions, thus reducing diagnosis and treatment delay. KardiaMobile AliveCor, Inc. The other key changes in the MDR over the MDD includes inclusion of medical purpose devices and active implantable medical devices AIMD , requirements for the manufacturers to update clinical data, technical documentation, and labeling; and generate and provide detailed clinical data to validate safety and performance claims and enforce unique device identification UDI for tracking.
Although these changes are meant to ensure a much safer, transparent and sustainable regulatory framework for the consumer, changeover on such a scale in a limited timeframe is a mammoth task for manufacturers and regulatory bodies to achieve. It was unclear whether the UK would comply with EU regulations [ ]. However, the UK Government, on 4 July , vowed to work closely with the EU in terms of medicines regulation to ensure public health and safety even after leaving the EU [ ].
The conformity assessment procedure ensures tighter control to be applied to the device in case the perceived risks associated with it is higher. For a low-risk i. However, it was argued in a report to the U. However, the new MDR, which is scheduled to be in force in has put more emphasis on clinical trials and evidence [ ]. On the other hand, the US Food and Drug Administration FDA requires the devices to ensure not only the safety and performance but also their clinical efficacy [ ].
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Furthermore, only one organization, the FDA, governs the entire process of device approval in the US. While this ensures better surveillance on the regulatory processes, however, often it turns out to be an expensive, rigid and lengthy process for manufacturers [ ]. However, the approval process of medical devices based on the predicate device and without rigorous new clinical evidence can deter the manufactures to carry out expensive and time-consuming clinical trials, which not only raise concerns in terms of device safety and efficacy but also may lessen the scope of device improvement and innovation [ ].
Health Canada, for example, categorizes the medical devices into four classes from Class I to Class IV based on the risks associated with the devices [ ]. However, the information required to file an application for Health Canada approval is approximately the same as that required in the US and EU [ ]. In this paper, we have presented a state-of-the-art survey on health and activity monitoring systems that exploit the embedded sensors in smartphones for measuring physiological parameters and tracking health conditions. The ubiquity of smartphones has grown enormously in the past decade.
In addition, the significant advances in sensor technologies in terms of size, cost, energy requirements and sensitivity has enabled the integration of a number of sensors into present-day smartphones. The embedded sensors in smartphones such as the image sensor, microphone, ambient light sensor and motion sensors coupled with modern high-speed data transfer technologies may assist people to lead an independent and active life while ensuring non-invasive monitoring of their health and physical well-being in a regular fashion without adding much to their personal expenses.
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The smartphone and its embedded sensors coupled with present-day information and communications technologies have opened a new window of opportunity for cost-effective remote healthcare services. The raw medical data thus obtained by the smartphone sensors can be sent over the internet to a remote healthcare facility for detailed investigation.
Thus, smartphones may play an incredible role in enabling a low-cost solution for early diagnosis through continuous monitoring, initial screening of diseases such as melanoma, and diabetic retinopathy and remote monitoring of the progression of some diseases. Owing to the high market penetration and ever-increasing computational capabilities of smartphones, there have been growing interests among the researchers and the manufacturers in building smartphone-based devices for healthcare and wellness purposes.
However, there remain some key challenges that need to be addressed prior to achieving a global acceptance of smartphones as medical devices. First, most of the works reported in the literature are based-on nonrandomized, non-blinded studies on a limited number of subjects using a proof-of-concept device. Further, the limited size and possible bias in the samples implies that the universal efficacy of the devices is still a critical concern. These blurred boundaries need to be resolved to safeguard the users from possible harmful consequences.
Although this process offers more flexibility to the manufacturers and reduces unnecessary delay in the approval process, it is, however, subject to the risk of compromised safety owing to varying standards, pricing and work ethics of different NBs. Fourth, approving a medical device based on a predicate may cause safety concerns and was therefore criticized by some experts. It was argued that some predicates were in the market even before any regulatory policies were implemented. Some predicate devices were never tested on humans and some were even recalled voluntarily from the market due to their poor performance, thus questioning the credibility of the predicate itself.
In addition, this process of device approval encourages the manufacturers to evade the expensive and time-consuming but critical clinical trials before bringing the product in the market. A centralized database or a dedicated app store of approved medical apps can be of immense benefit for both product developers and consumers. The centralized system, similar to other app stores, can serve as a common platform for both the users and the developers.
It can also review and recommend the apps based on the quality, reliability, medical effectiveness, safety, privacy and value-for-money. Seventh, one of the major concerns for smartphone-based healthcare systems is associated with the privacy and security of any sensitive medical information. However, to date, most publications either did not address these critical issues or did so in a cursory manner. Therefore, more efforts are needed to develop and implement robust algorithms to ensure data privacy and information security.
All authors carefully reviewed the final manuscript. National Center for Biotechnology Information , U. Journal List Sensors Basel v.
Sensors Basel. Published online May 9. Sumit Majumder 1 and M. Jamal Deen. Author information Article notes Copyright and License information Disclaimer. Received Mar 29; Accepted Apr This article has been cited by other articles in PMC. Abstract Over the past few decades, we have witnessed a dramatic rise in life expectancy owing to significant advances in medical science and technology, medicine as well as increased awareness about nutrition, education, and environmental and personal hygiene.
Keywords: smartphone, remote healthcare, mHealth, telehealth, medical device, regulation, smartphone sensor.
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Introduction Life expectancy in many countries has increased drastically over the last several decades. Table 1 Smartphone sensors used for health monitoring. Open in a separate window. Figure 1.