What’s New in the Patient Safety World

July 2018



·       FDA on Surgical Fires

·       Yes, You Can Reduce Your SSI Rates

·       Contact Precautions Conundrum

·       Hearing Loss and Patient Safety




FDA on Surgical Fires



The FDA has just released a safety communication regarding surgical fires (FDA 2018). Though it does not contain any new revelations, it provides good recommendations to reduce surgical fires in a concise, practical manner.


It begins with a discussion of the fire triad and appropriately emphasizes the role of supplemental oxygen. As we have emphasized in so many of our own columns on surgical fires, it stresses that an open oxygen delivery system (eg. nasal cannula or mask) presents a greater risk of fire than a closed delivery system (laryngeal mask or endotracheal tube). It also notes the importance of draping techniques that avoid accumulation of oxygen in the surgical field.


We’ve discussed that surgical fires have in recent years been occurring more often in relatively “minor” procedures (eg. temporal artery biopsies, plastic procedures or removal of skin lesions on the head/neck). In such cases there may be no need for supplemental oxygen, yet supplemental oxygen is sometimes routinely provided. In others, use of supplemental oxygen is not anticipated but something occurs during the procedure that leads to its use. In both cases, it is critical that there be clear communication and coordination between the anesthesiologist and surgeon regarding cessation of oxygen administration when a heat source is about to be used.


The FDA recommends that health care professionals and staff who perform surgical procedures be trained in practices to reduce surgical fires. That training should include factors that increase the risk of surgical fires, how to manage fires that do occur, periodic fire drills, how to use carbon dioxide (CO2) fire extinguishers near or on patients, and evacuation procedures.


The FDA recommends a fire risk assessment at the beginning of each surgical procedure. We recommend that a fire risk assessment be done both during the presurgical “huddle” and as part of the surgical “timeout”. We continue to promote use of the SF VAMC Surgical Fire Risk Assessment Protocol, which can be embedded into your safe surgery checklist.


The FDA emphasizes the importance of communication, not only between the anesthesia professional delivering medical gases and the surgeon controlling the ignition source, but also amongst the operating room staff applying skin preparation agents and drapes.


The advisory has good recommendations regarding surgical suite items that may serve as fuel sources. It emphasizes the need to allow adequate drying time and prevent alcohol-based antiseptics from pooling during skin preparation and assess for pooling or other moisture to ensure dry conditions prior to draping. We’re glad to see they included one of our favorites to avoid in head/neck cases, the 26 ml applicator, in their recommendations (see our January 10, 2017 Patient Safety Tip of the Week “The 26-ml Applicator Strikes Again!”). But the FDA also cautions us to be aware of other surgical suite items that may serve as a fuel source, including products that may trap oxygen, such as surgical drapes, towels, sponges, and gauze – even those which claim to be "flame-resistant." They also mention patient-related sources such as hair and gastrointestinal gases. We’ve deferred including an article about a surgical fire related to flatus but, since the FDA mentions it, you can read it for yourselves (The Asahi Shimbun 2016)!


The section about devices that may serve as an ignition source is particularly good. First, it advises that alternatives be considered to using an ignition source for surgery of the head, neck, and upper chest if high concentrations of supplemental oxygen (greater than 30 percent) are being delivered. As above, if an ignition source must be used, be aware that it is safer to do so after allowing time for the oxygen concentration in the room to decrease. It may take several minutes for a reduction of oxygen concentration in the area even after stopping the gas or lowering its concentration.


It reminds us to inspect all instruments for evidence of insulation failure (device, wires, and connections) prior to use (and do not use if any defects are found). And it reminds us that, in addition to serving as an ignition source, monopolar energy use can directly result in unintended patient burns from capacitive coupling and intra-operative insulation failure. It recommends the following if a monopolar electrosurgical unit (ESU) is used:

When not in use, ignition sources, such as ESUs, electrocautery devices, fiber-optic illumination light sources and lasers should be placed in a designated area away from the patient (e.g., in a holster or a safety cover) and not directly on the patient or surgical drapes. It also reminds us about other less common potential ignition sources, such as drills and burrs, argon beam coagulators, and fiber-optic illuminators.


Lastly, it describes what to do if a fire occurs:


Surgical fires are devastating and should never occur. Using the precautions noted above and in our multiple columns on surgical fires listed below, you should be able to prevent them. But you must ensure that all staff are educated about surgical fires and do appropriate drills so that everyone knows their role in the unfortunate event that one should occur.



Our prior columns on surgical fires:








FDA (US Food & Drug Administration). Recommendations to Reduce Surgical Fires and Related Patient Injury: FDA Safety Communication. FDA Safety Communication 2018; May 29, 2018




The Asahi Shimbun. Fart blamed for fire during surgery; patient seriously burned. The Asahi Shimbun 2016; October 30, 2016




SF VAMC Surgical Fire Risk Assessment Protocol







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Yes, You Can Reduce Your SSI Rates



A year ago, in our June 2017 What's New in the Patient Safety World column “New CDC Guideline for SSI Prevention”, we noted there had been a flurry of updates on guidelines for prevention of SSI’s (surgical site infections). The American College of Surgeons (Ban 2016), the American College of Obstetricians and Gynecologists (Pellegrini 2016), and WHO (Allegranzi 2016a, Allegranzi 2016b) had published their updated guidelines in 2016 and the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA) published their update in 2014 (Anderson 2014). And the Centers for Disease Control and Prevention had just published it’s new guidelines (Berríos-Torres 2017). See our June 2017 What's New in the Patient Safety World column “New CDC Guideline for SSI Prevention” for details of that CDC guideline.


So, are we seeing improvements in SSI rates as organizations implement all these recommendations? Statistics recently released by AHRQ show that national rates for surgical site infections have been flat between 2014 and 2016 (AHRQ 2018a). But a few recent studies suggest that implementation of bundles using the key items from the guidelines mentioned above are, indeed, producing positive results.


Fifteen hospitals participated in a statewide collaborative in Hawaii to implement the Comprehensive-Unit-based-Safety-Program (CUSP) and individualized bundles of interventions to reduce SSI’s (Lin 2018). We consider the CUSP program, pioneered by Johns Hopkins and AHRQ, as a key to improving hospital safety culture and paving the way for success of many quality improvement projects (see our March 2011 What's New in the Patient Safety World column “Michigan ICU Collaborative Wins Big” for comments about CUSP and links to resources).


While the bundles were individualized by each hospital, the most common interventions implemented were: (1) reliable chlorhexidine wash/wipe before surgery/surgical prep; (2) appropriate antibiotic choice/dose/timing; (3) standardized post-surgical debriefing; (4) differentiating clean-dirty-clean with anastomosis tray/closing tray.


Over a 2-year period, the colorectal SSI rate for the collaborative decreased from 12.08 percent to 4.63 percent, a 61.7 percent reduction. Moreover, safety culture, measured by AHRQ Hospital Survey on Patient Safety Culture (HSOPS), improved in 10 of 12 domains.


A similar successful implementation of an SSI Bundle occurred for gynecological surgery at Yale New Haven Hospital. (Andiman  2018). Because of a higher-than-expected surgical site infection rate, a quality improvement program was implemented to address SSI’s after hysterectomy. A multidisciplinary team designed a surgical site infection prevention bundle that consisted of chlorhexidine-impregnated preoperative wipes, standardized aseptic surgical preparation, standardized antibiotic dosing, perioperative normothermia, surgical dressing maintenance, and direct feedback to clinicians when the protocol was breached. The program was associated with a more than 50% reduction in the SSI rate. Patients who underwent surgery after the bundle was fully implemented had a reduced risk for overall surgical site infection (4.5% vs 1.9%). After adjusting for clinical characteristics, patients who underwent surgery after full implementation were less likely to develop a surgical site infection (adjusted odds ratio [OR] 0.46). Superficial surgical site infection rate decreased from 2.1% before full

bundle implementation to 0.8% after full bundle implementation. The rate of deep and organ space infections fell from 3.0% to a mean of 1.2% (and was zero in some of these months) during the last 8 months.


Several components of the Yale bundle merit comment. Their antibiotic protocol added a provision to ensure re-dosing when the procedure duration exceeded 3 hours. They also added metronidazole for cases in which bowel involvement was anticipated or in cases considered especially high risk for infection.


Intraoperative normothermia was achieved using forced-air warming devices but patients were also provided with forced-air warming for their own use preoperatively.


Lastly, the authors attributed much of the success in changing behavior to the last item (direct feedback) since surgical site infection incidence continually decreased after formalization of feedback as a component to the bundle.


Because various components of the bundle were added incrementally, they used multivariable regression models to assess individual bundle components. But these showed no statistically significant difference in risk for surgical site infection associated with maintenance of intraoperative normothermia, antibiotic standardization, or direct feedback.


Previously, in our September 2016 What's New in the Patient Safety World column “More on Preventing HAI’s”, we highlighted a study which utilized a bundle of evidence-based interventions in patients undergoing spine surgery (discectomy, decompression, spinal augmentation or spinal fusion) and found surgical site infections declined by 50% after implementation (Featherall 2016). Components of the “bundle” were:

1.     screening for Staphylococcus aureus nasal colonization and decolonization with mupirocin

2.     self-preparation bath with chlorhexidine gluconate

3.     self-preparation with chlorhexidine gluconate wipes

4.     storage optimization of operating room supplies

5.     preoperative antibiotic administration algorithm

6.     staff training on betadine scrub and paint

7.     intrawound vancomycin in instrumented cases

8.     postoperative early patient mobilization

9.     wound checks at 2 and 6 weeks postoperatively

The number needed to treat (NNT) to prevent one infection was 47 patients. In addition to the 50 percent decline in SSIs there was an $866 cost reduction per case.


When we discussed the CDC guideline in our June 2017 What's New in the Patient Safety World column “New CDC Guideline for SSI Prevention” we noted as striking the sheer number of practices for which there was insufficient evidence to make a recommendation. The CDC guideline focused heavily on antimicrobial prophylaxis, antiseptic prophylaxis, glucose control, and normothermia, all facets with a solid evidence base. So it is no surprise to see some variation in the components of the bundles used at individual hospitals. They all did include core elements related to antimicrobial prophylaxis and skin antiseptic techniques. It is almost impossible to determine which components of bundles are most responsible for success. But don’t overlook the role played by the improvement in safety culture seen when multiple disciplines come together in a project with a common goal.


AHRQ also has a new Patient Safety Primer on Surgical Site Infections (AHRQ 2018b). Also, a very interesting study was published on use of process mapping to improve infection prevention activities and surgical safety in countries with limited resources (Forrester 2018). A checklist-based quality improvement program was implemented to improve compliance with best practices and process mapping helped identify barriers to using best practices. The latter included things like barriers to using alcohol-based hand solution due to skin irritation, inconsistent administration of prophylactic antibiotics due to variable delivery outside of the operating theater, inefficiencies in assuring sterility of surgical instruments through lack of confirmatory measures, and occurrences of retained surgical items through inappropriate guidelines, staffing, and training in proper routine gauze counting. They found that enumerating the steps involved in surgical infection prevention using a process mapping technique helped identify opportunities for improving adherence and plotting contextually relevant solutions, resulting in superior compliance with antiseptic standards. We dare say that such process mapping would likely have a positive impact even in those countries and settings that are resource-rich!







Ban KA, Minei JP, Laronga C, et al, American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. Journal of the American College of Surgeons 2016; Published online: November 30, 2016




Pellegrini JE, Toledo P, Soper DE, et al. Consensus Bundle on Prevention of Surgical Site Infections after Major Gynecologic Surgery. Obstetrics & Gynecology 2016; Published ahead of print (Post Author Corrections): December 02, 2016




Allegranzi B, Bischoff P, de Jonge S, et al; WHO Guidelines Development Group. New WHO recommendations on preoperative measures for surgical site infection prevention: an evidence-based global perspective. Lancet Infect Dis 2016; 16(12): e276-e287




Allegranzi B, Zayed B, Bischoff P, et al; WHO Guidelines Development Group. New WHO recommendations on intraoperative and postoperative measures for surgical site infection prevention: an evidence-based global perspective. Lancet Infect Dis 2016; 16(12): e288-e303




Anderson D, Podgornny K, Berrios-Torres S, et al. Strategies to Prevent Surgical Site Infections in Acute Care Hospitals: 2014 Update. Infection Control and Hospital Epidemiology 2014; 35(6): 605-627 (June 2014) electronically published May 5, 2014




Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. for the Healthcare Infection Control Practices Advisory Committee . Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg 2017; Published online May 3, 2017




AHRQ (Agency for Healthcare Research and Quality). AHRQ National Scorecard on Hospital-Acquired Conditions. Updated Baseline Rates and Preliminary Results 2014–2016. AHRQ 2018; June 2018




Lin DM, Carson KA, Lubomski LH, et al. Statewide Collaborative to Reduce Surgical Site Infection: Results of the Hawaii Surgical Unit-based Safety Program. J Amer Coll Surg 2018; Published online: May 18, 2018




Andiman SE, Xu X, Boyce JM, et al. Decreased Surgical Site Infection Rate in Hysterectomy: Effect of a Gynecology-Specific Bundle. Obstetrics & Gynecology 2018; Published Ahead of Print




Featherall J, Miller JA, Bennett EE, et al. Implementation of an Infection Prevention Bundle to Reduce Surgical Site Infections and Cost Following Spine Surgery. JAMA Surgery 2016; Online First July 20, 2016




AHRQ (Agency for Healthcare Research and Quality). Patient Safety Primer.

Surgical Site Infections. AHRQ 2018; June 2018




Forrester JA, Koritsanszky LA, Amenu D, et al. Developing Process Maps as a Tool for a Surgical Infection Prevention Quality Improvement Initiative in Resource-Constrained Settings. J Am Coll Surg 2018; 226(6): 1103-1116.e3







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Contact Precautions Conundrum



Use of contact precautions has been a mainstay in the prevention of transmission of infectious diseases within hospitals. But contact precautions do have a downside (see our multiple columns listed below). Previous research has shown that patients in contact isolation have less contact by healthcare workers (and visitors) and this may lead to errors and omissions in care and other unintended consequences like decubiti, delirium, falls, DVT, medication errors, and fluid/electrolyte disorders among other preventable adverse events. In addition, depression, anxiety, and lower satisfaction have been found more often in patients on contact isolation. Hence, a conundrum: how should we use contact precautions (who, when, how long, etc.)?


A new study found that, after discontinuing routine CP (contact precautions) for endemic MRSA/VRE, the rate of noninfectious adverse events declined, especially in patients who no longer required isolation (Martin 2018). Noninfectious adverse events (ie, postoperative respiratory failure, hemorrhage/hematoma, thrombosis, wound dehiscence, pressure ulcers, and falls or trauma) decreased by 19% (from 12.3 to 10.0 per 1,000 admissions) from the preintervention to the postintervention period. There was no significant difference in the rate of infectious adverse events after CP discontinuation. Patients with MRSA/VRE showed the largest reduction in noninfectious adverse events after CP discontinuation, with a 72% reduction (from 21.4 to 6.08 per 1,000 MRSA/VRE admissions).


A previous study by Martin and colleagues (Martin 2016) had shown that removal of contact precautions (CPs) for endemic MRSA and vancomycin-resistant Enterococcus (VRE) did not increase the prevalence of either pathogen and resulted in hospital savings of an estimated $643,776 in one year.


Another recent study (Bearman 2018) investigated the impact of discontinuing contact precautions among patients infected or colonized with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) on rates of healthcare-associated infection (HAI). CP’s were discontinued as one of a series of infection prevention interventions. The rate of HAI’s declined throughout the study period. Infection rates for MRSA and VRE decreased by 1.31 and 6.25 per 100,000 patient days, respectively, and the infection rate decreased by 2.44 per 10,000 patient days for device-associated HAI following discontinuation of contact precautions. They concluded that discontinuation of contact precautions for patients infected or colonized with MRSA or VRE, when combined with horizontal infection prevention measures, was not associated with an increased incidence of MRSA and VRE device-associated infections.


These studies are reassuring. The current Martin study supports the hypothesis that contact precautions are associated with non-infectious adverse events. But it also suggests that we can, in fact, reduce the use of contact precautions and reduce the rates of those non-infectious adverse events without increasing the rates of infections.




Some of our prior columns on the unintended consequences of contact isolation:







Martin EM, Bryant B, Grogan TR, et al. Noninfectious Hospital Adverse Events Decline After Elimination of Contact Precautions for MRSA and VRE. Infect Control Hosp Epidemiol. 2018; Published online: 10 May 2018, pp. 1-9




Martin EM, Russell D, Rubin Z, et al. Elimination of Routine Contact Precautions for Endemic Methicillin-Resistant Staphylococcus aureus and Vancomycin-Resistant Enterococcus: A Retrospective Quasi-Experimental Study. Infect Control Hosp Epidemiol. 2016; 37(11): 1323-1330




Bearman G, Abbas S, Masroor N, et al. Impact of Discontinuing Contact Precautions for Methicillin-Resistant Staphylococcus aureus and Vancomycin-Resistant Enterococcus: An Interrupted Time Series Analysis. Infect Control Hosp Epidemiol 2018; 39(6): 676-682






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Hearing Loss and Patient Safety



Hearing loss, alone or in combination with impairment of other sensory modalities, can have an impact on patient safety.


In our September 12, 2017 Patient Safety Tip of the Week “Can You Hear Me Now?” we stressed that even minor degrees of hearing loss may impair communication between healthcare professionals and patients. Cudmore and colleagues (Cudmore 2017) found that, of 100 adults age 60 and older, 57 reported having some degree of hearing loss and 43 of the 100 reported mishearing a physician or nurse in a primary care or hospital setting. They identified several themes (in order of frequency): general mishearing, consultation content, physician-patient or nurse-patient communication breakdown, hospital setting, use of language, selective deafness. Some patients especially noted problems with similar sounding words. Others complained that the physician or nurse did not look at them while talking (we’ll bet some of these patients were lip reading) and others complained the healthcare professional spoke too fast or in too low a volume.


The accompanying editorial (Weinreich 2017) notes patients with hearing loss are missing instructions, missing diagnoses, and missing medication information. Weinreich notes that, in addition to physicians speaking too quickly or quietly, background noise may cause patients to miss messages. She notes we need to know when our patients have hearing loss and change how we communicate with hearing loss patients. She notes we need to:


Never assume that what is heard is actually understood. That emphasizes the concepts of “hear back” and “teach back” which we have stressed in our columns on health literacy and numeracy. (“Hear back” is obviously also critical in communication between healthcare professionals).


In all healthcare settings you need to assess whether your patients have hearing impairment (some of us won’t admit it!). Use some of the techniques noted above in the Cudmore and Weinreich articles. And, perhaps most importantly, use hear back and teach back to make sure your patients truly understand what you are trying to communicate to them.


So, one way hearing loss presents a threat to patient safety is through impairment of communication. But there are other ways that hearing loss is a patient safety issue. Hearing loss and impairment of other sensory modalities are risk factors for delirium. In our numerous columns on delirium, you’ve heard us note the importance of ensuring that hospitalized patients have their hearing aids and eye glasses brought in from home as part of delirium prevention or management programs.


And our February 2018 What's New in the Patient Safety World column “Global Sensory Impairment and Patient Safety” discussed the “multiple sensory deficit syndrome” as a major cause of impaired ambulation and falls. Many older patients have impairments of sensory function (such as vision, hearing, vestibular function, and proprioception) that individually are not severe enough to produce disability but collectively have an additive or synergistic effect that does result in disability. It also discussed a related concept, “global sensory impairment” (GSI), and its impact on overall health. Correia and colleagues assessed the 5 classical primary sensations (vision, hearing, touch, taste, and smell) in community-dwelling U.S. adults aged 57 to 85 (Correia 2016). They found that two-thirds of subjects had two or more sensory deficits, 27% had just one, and 6% had none. Seventy-four percent had impairment in taste, 70% in touch, 22% in smell, 20% in corrected vision, and 18% in corrected hearing. Older adults, men, African Americans, and Hispanics had greater multisensory impairment. Global Sensory Impairment (GSI) is also a predictor of morbidity and mortality in older adults (Pinto 2017).


In the past couple months, there have been several studies demonstrating the impact of hearing loss on health care utilization and costs.


Lin and colleagues (Lin 2018) did a cross-sectional analysis of responses of a nationally representative sample of 232.2 million individuals 18 years or older who participated in the National Health Interview Survey from 2007 to 2015 and responded to the questions related to the hearing and injury modules. 50.1% considered their hearing to be less than excellent. Accidental injuries occurred in 2.8% of survey respondents. In comparison with normal-hearing adults, the odds of accidental injury were higher in those with a little trouble hearing (4.1%; OR, 1.6), moderate trouble hearing (4.2%; OR, 1.7), and a lot of trouble hearing (4.8%; OR, 1.9). Work- and leisure-related injuries were more prevalent among those with self-perceived hearing difficulty.


Another recent study analyzed healthcare costs of insured older Americans found more than 20% higher total healthcare payments over 18 months for a group of insured individuals with hearing loss regardless of insurance type or hearing services use (Simpson 2018).


So, is there any evidence to suggest that correction of hearing has a positive impact on these healthcare utilization and cost issues? Mahmoudi and colleagues (Mahmoudi 2018) used the nationally representative 2013-2014 Medical Expenditure Panel Survey data to evaluate the use of hearing aids among 1336 adults aged 65 years or older with hearing loss. Use of hearing aids was associated with reduced probability of any ED visits and any hospitalizations and in reducing the number of nights in the hospital.


Of course, when we hear about accidental injuries in hearing-impaired individuals, we first of all attribute them to failure to hear things like honking horns or warning shouts. But hearing loss may have more subtle contributions to accidental injuries. While we usually think about vision, vestibular function, cerebellar function, and proprioception as being the primary modalities that keep us from falling, hearing also plays a role. You may not realize it but, when you are walking on a snow-covered walkway, a subtle change in auditory feedback from your footsteps might alert you that you have reached a dangerous patch of ice. Or you might miss the warning “creak” in a faulty stairway step or ladder rung.


So when you are evaluating your patients, whether during an annual risk factor assessment session or a health maintenance visit or an acute illness visit, pay careful attention to whether they may have hearing impairment. That is key to help prevent any miscommunication that could have adverse effects, but also to identify a potentially modifiable risk factor. Traditional Medicare does not currently cover the cost of hearing aids, though some Medicare Advantage plans may cover some costs or provide discounts for hearing aids. But you should at least point out the above studies to such patients so they understand the importance of hearing correction to the overall health status.


In an editorial accompanying the Mahmoudi study, Wallhagen (Wallhagen 2018) points out that hearing assessment can be simple and not time consuming. You can use a combination of a simple question and a brief objective test like a finger rub or whisper test, or a brief questionnaire like the Hearing Handicap Inventory for the Elderly. She points out that this takes minimal time and can be scheduled at regular intervals, much like the foot examination for a patient with diabetes.







Cudmore V, Henn P, O’Tuathaigh CMP, et al. Age-Related Hearing Loss and Communication Breakdown in the Clinical Setting. JAMA Otolaryngol Head Neck Surg 2017; Published online August 24, 2017




Weinreich HM. Hearing Loss and Patient-Physician CommunicationThe Role of an Otolaryngologist. JAMA Otolaryngol Head Neck Surg 2017; Published online August 24, 2017




Correia C, Lopez KJ, Wroblewski KE et al. Global sensory impairment in older adults in the United States. J Am Geriatr Soc 2016; 64: 306-313




Pinto JM, Wroblewski KE, Huisingh-Scheetz M, et al. Global Sensory Impairment Predicts Morbidity and Mortality in Older U.S. Adults. J Am Geriatr Soc 2017; 65: 2587-2595




Lin HW, Mahboubi H, Bhattacharyya N. Self-reported Hearing Difficulty and Risk of Accidental Injury in US Adults, 2007 to 2015. JAMA Otolaryngol Head Neck Surg 2018; Published online March 22, 2018




Simpson AN, Simpson KN, Dubno JR. Healthcare Costs for Insured Older U.S. Adults with Hearing Loss. Journal of the American Geriatrics Society 2018; First published:  24 May 2018




Mahmoudi E, Zazove P, Meade M, et al. Association Between Hearing Aid Use and Health Care Use and Cost Among Older Adults With Hearing Loss. JAMA Otolaryngol Head Neck Surg 2018; Published online April 26, 2018




Wallhagen MI. Hearing Aid Use and Health Care Costs Among Older Adults. JAMA Otolaryngol Head Neck Surg 2018; Published online April 26, 2018







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