FDA Warns against Marketing Hearing Aids as OTC Devices

​The U.S. Food and Drug Administration (FDA) has issued a letter to hearing aid manufacturers warning them not to market hearing aids as over-the-counter devices and reminding them that such a category of product does not exist until the final OTC regulations are published. (http://bit.ly/2OCiMMm.) William Maisel, MD, MPH, stated in the letter that no products that are claimed to address hearing loss are, or can claim to be, OTC hearing aids until that time. "Currently, hearing aids continue to be restricted devices, for which sales must follow applicable federal and state requirements," he wrote. Under section 709 of the FDA Reauthorization Act of 2017 (FDARA), the FDA have until Aug. 18, 2020 to consider public comments and publish the final regulations within 180 days after the close of the comment period. 

Published: 8/3/2018 2:30:00 PM

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FDA Warns against Marketing Hearing Aids as OTC Devices

​The U.S. Food and Drug Administration (FDA) has issued a letter to hearing aid manufacturers warning them not to market hearing aids as over-the-counter devices and reminding them that such a category of product does not exist until the final OTC regulations are published. (http://bit.ly/2OCiMMm.) William Maisel, MD, MPH, stated in the letter that no products that are claimed to address hearing loss are, or can claim to be, OTC hearing aids until that time. "Currently, hearing aids continue to be restricted devices, for which sales must follow applicable federal and state requirements," he wrote. Under section 709 of the FDA Reauthorization Act of 2017 (FDARA), the FDA have until Aug. 18, 2020 to consider public comments and publish the final regulations within 180 days after the close of the comment period. 

Published: 8/3/2018 2:30:00 PM

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FDA Warns against Marketing Hearing Aids as OTC Devices

​The U.S. Food and Drug Administration (FDA) has issued a letter to hearing aid manufacturers warning them not to market hearing aids as over-the-counter devices and reminding them that such a category of product does not exist until the final OTC regulations are published. (http://bit.ly/2OCiMMm.) William Maisel, MD, MPH, stated in the letter that no products that are claimed to address hearing loss are, or can claim to be, OTC hearing aids until that time. "Currently, hearing aids continue to be restricted devices, for which sales must follow applicable federal and state requirements," he wrote. Under section 709 of the FDA Reauthorization Act of 2017 (FDARA), the FDA have until Aug. 18, 2020 to consider public comments and publish the final regulations within 180 days after the close of the comment period. 

Published: 8/3/2018 2:30:00 PM

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FDA Warns against Marketing Hearing Aids as OTC Devices

​The U.S. Food and Drug Administration (FDA) has issued a letter to hearing aid manufacturers warning them not to market hearing aids as over-the-counter devices and reminding them that such a category of product does not exist until the final OTC regulations are published. (http://bit.ly/2OCiMMm.) William Maisel, MD, MPH, stated in the letter that no products that are claimed to address hearing loss are, or can claim to be, OTC hearing aids until that time. "Currently, hearing aids continue to be restricted devices, for which sales must follow applicable federal and state requirements," he wrote. Under section 709 of the FDA Reauthorization Act of 2017 (FDARA), the FDA have until Aug. 18, 2020 to consider public comments and publish the final regulations within 180 days after the close of the comment period. 

Published: 8/3/2018 2:30:00 PM

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Using the Language ENvironment Analysis (LENA) System to Investigate Cultural Differences in Conversational Turn Count

Purpose

This study investigates how the variables of culture and hearing status might influence the amount of parent–child talk families engage in throughout an average day.

Method

Seventeen Vietnamese and 8 Canadian families of children with hearing loss and 17 Vietnamese and 13 Canadian families with typically hearing children between the ages of 18 and 48 months old participated in this cross-comparison design study. Each child wore a Language ENvironment Analysis system digital language processor for 3 days. An automated vocal analysis then calculated an average conversational turn count (CTC) for each participant as the variable of investigation. The CTCs for the 4 groups were compared using a Kruskal–Wallis test and a set of planned pairwise comparisons.

Results

The Canadian families participated in significantly more conversational turns than the Vietnamese families. No significant difference was found between the Vietnamese or the Canadian cohorts as a function of hearing status.

Conclusions

Culture, but not hearing status, influences CTCs as derived by the Language ENvironment Analysis system. Clinicians should consider how cultural communication practices might influence their suggestions for language stimulation.

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Code-Switching in Highly Proficient Spanish/English Bilingual Adults: Impact on Masked Word Recognition

Purpose

The purpose of this study was to evaluate the impact of code-switching on Spanish/English bilingual listeners' speech recognition of English and Spanish words in the presence of competing speech-shaped noise.

Method

Participants were Spanish/English bilingual adults (N = 27) who were highly proficient in both languages. Target stimuli were English and Spanish words presented in speech-shaped noise at a −14-dB signal-to-noise ratio. There were 4 target conditions: (a) English only, (b) Spanish only, (c) mixed English, and (d) mixed Spanish. In the mixed-English condition, 75% of the words were in English, whereas 25% of the words were in Spanish. The percentages were reversed in the mixed-Spanish condition.

Results

Accuracy was poorer for the majority (75%) and minority (25%) languages in both mixed-language conditions compared with the corresponding single-language conditions. Results of a follow-up experiment suggest that this finding cannot be explained in terms of an increase in the number of possible response alternatives for each picture in the mixed-language condition relative to the single-language condition.

Conclusions

Results suggest a cost of language mixing on speech perception when bilingual listeners alternate between languages in noisy environments. In addition, the cost of code-switching on speech recognition in noise was similar for both languages in this group of highly proficient Spanish/English bilingual speakers. Differences in response-set size could not account for the poorer results in the mixed-language conditions.

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Using the Language ENvironment Analysis (LENA) System to Investigate Cultural Differences in Conversational Turn Count

Purpose

This study investigates how the variables of culture and hearing status might influence the amount of parent–child talk families engage in throughout an average day.

Method

Seventeen Vietnamese and 8 Canadian families of children with hearing loss and 17 Vietnamese and 13 Canadian families with typically hearing children between the ages of 18 and 48 months old participated in this cross-comparison design study. Each child wore a Language ENvironment Analysis system digital language processor for 3 days. An automated vocal analysis then calculated an average conversational turn count (CTC) for each participant as the variable of investigation. The CTCs for the 4 groups were compared using a Kruskal–Wallis test and a set of planned pairwise comparisons.

Results

The Canadian families participated in significantly more conversational turns than the Vietnamese families. No significant difference was found between the Vietnamese or the Canadian cohorts as a function of hearing status.

Conclusions

Culture, but not hearing status, influences CTCs as derived by the Language ENvironment Analysis system. Clinicians should consider how cultural communication practices might influence their suggestions for language stimulation.

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